natgillin/translations-raw huggingface dataset:
Seponér behandlingen permanent eller hvis lægen skønner, at det bedste for patienten er at fortsætte, så afbryd behandlingen, indtil toksiciteten er reduceret til grad 0-1
Discontinue permanently or If physician deems it to be in the patient's best interest to continue, interrupt until resolved to grade 0-1
Modificeret XELIRI + bevacizumab (ITT: N = 120)
Modified XELIRI + bevacizumab (ITT: N = 120)
Ved afslutningen af behandlingen havde 37 % af patienterne i XELIRI-armen og 26 % af patienterne i FOLFIRI-armen ingen tegn på sygdommen (p = 0,56).
At the end of treatment, 37 % of patients in the XELIRI and 26 % of patients in the FOLFIRI arm were without evidence of the disease (p = 0.56).
• blodfortyndende medicin (coumarin eller warfarin)
• blood-thinning medicines (coumarin, warfarin)
Følgende faktorer var præspecificerede i den statistiske analyseplan for inklusion i modellen: Alder, tid fra operation til randomisering, køn, karcinoembryonisk antigen (CEA)-værdier ved baseline, lymfeknuder ved baseline samt land.
The following factors were pre-specified in the statistical analysis plan for inclusion in the model: age, time from surgery to randomisation, gender, carcinoembryonic antigen (CEA) levels at baseline, lymph nodes at baseline, and country.
Neurotoksicitet, Tremor, Neuralgi,
Neurotoxicity, Tremor, Neuralgia,
Disse resultater tyder på en interaktion, sandsynligvis på grund af capecitabins hæmning af cytokrom P450 2C9-isoenzymsystemet.
These results suggest an interaction, probably due to an inhibition of the cytochrome P450 2C9 isoenzyme system by capecitabine.
Dosisjustering for næste serie/dosis (% af begyndelsesdosis)
Dose changes within a treatment cycle Dose adjustment for next cycle/dose (% of starting dose)
Creatininclearance påvirkede den systemiske eksponering af 5'-DFUR (35 % stigning i AUC, når creatininclearance aftog med 50 %) og FBAL (114 % stigning i AUC, når creatininclearance aftog med 50 %).
Creatinine clearance was found to influence the systemic exposure to 5'-DFUR (35 % increase in AUC when creatinine clearance decreases by 50 %) and to FBAL (114 % increase in AUC when creatinine clearance decreases by 50 %).
• hvis du tidligere har reageret kraftigt på behandling med fluorpyrimidin (en gruppe lægemidler mod kræft, bl.a. fluorouracil)
• if you previously have had severe reactions to fluoropyrimidine therapy (a group of anticancer medicines such as fluorouracil),
Oxaliplatin på dag 1, hver 2. uge
Oxaliplatin on Day 1, every 2 weeks
Adjuverende behandling af patienter med stadium III-kolonkræft anbefales i en periode på 6 måneder.
Adjuvant treatment in patients with stage III colon cancer is recommended for a total of 6 months.
Capecitabin 1.000 mg/m² oral 2 gange daglig
Capecitabine 1,000 mg/m² oral twice daily
Hvis capecitabin og cisplatin anvendes i kombination, frarådes anvendelse af vitamin B6 (pyridoxin) til behandling af symptomatisk eller sekundær profylaktisk behandling af HFS, da der er offentliggjort meddelelser om, at det kan nedsætte virkningen af cisplatin.
When capecitabine and cisplatin are used in combination, the use of vitamin B6 (pyridoxine) is not advised for symptomatic or secondary prophylactic treatment of HFS, because of published reports that it may decrease the efficacy of cisplatin.
Administration Capecitabine medac tabletter skal synkes sammen med vand inden for 30 minutter efter et måltid.
Method of administration Capecitabine medac tablets should be swallowed with water within 30 minutes after a meal.
• hvis du har eller har haft hjerteproblemer (f.eks. uregelmæssig hjerterytme eller smerter i brystet, kæben og ryggen ved fysisk anstrengelse på grund af problemer med blodtilførslen til hjertet)
• if you have or had heart problems (for example an irregular heart beat or pains to the chest, jaw and back, brought on by physical effort and due to problems with the blood flow to the heart),
Efter oral administration absorberes capecitabin hurtigt og i stort omfang efterfulgt af en omfattende omdannelse til metabolitterne 5'-DFCR og 5‘-DFUR.
After oral administration, capecitabine is rapidly and extensively absorbed, followed by extensive conversion to the metabolites, 5'-DFCR and 5'-DFUR.
Farmakoterapeutisk klassifikation: Pyrimidin-analoger, antineoplastiske stoffer, ATC-kode: L01BC06
Pharmacotherapeutic group: Pyrimidine analogues, antineoplastic agents, ATC code: L01BC06
Du skal fortælle din læge, hvis du er overfølsom over for eller reagerer kraftigt på dette lægemiddel
You must inform your doctor if you know that you have an allergy or over-reaction to this medicine,
Tabel 3 Dosisreduktion af capecitabin (3-ugers-serier eller kontinuerlig behandling) Toksicitet graduering*
Table 3 Capecitabine dose reduction schedule (3-weekly cycle or continuous treatment) Toxicity grades*
Andre bivirkninger, der er set i denne forbindelse, er:
Other side-effects seen in this setting are the following:
I kombination med andre lægemidler kan den almindelige dosis for en voksen være mindre end 1.250 mg/m² legemsoverfladeareal, og det kan være nødvendigt, at du tager tabletterne i et andet tidsinterval (for eksempel hver dag uden pause).
In combination with other medicines the usual dose for adults may be less than 1,250 mg/m² of body surface area, and you may need to take the tablets over a different time period (e.g. every day, with no rest period).
Inkorporeringen af 5-FU medfører hæmning af ribonukleinsyre (RNA) og proteinsyntesen.
The incorporation of 5-FU also leads to inhibition of ribonucleic acid (RNA) and protein synthesis.
Der forekom ingen signifikant forskel i eksponeringen for andre metabolitter (5´-DFCR, 5´-DFUR og 5-FU).
No significant differences occurred in the exposure to other metabolites (5'-DFCR, 5'-DFUR, and 5-FU).
Parameter: Progressionsfri overlevelse EPP ITT Parameter: Samlet overlevelse EPP ITT
Parameter: Progression-free survival EPP ITT Parameter: Overall survival EPP ITT
XELIRI er blevet sammenlignet med 5-FU + irinotecan (FOLFIRI) hos patienter med metastatisk kolorektalkræft i tre randomiserede studier.
The XELIRI has been compared with 5-FU + irinotecan (FOLFIRI) in three randomised studies in patients with metastatic colorectal cancer.
Capecitabin kan inducere alvorlige hudreaktioner såsom Stevens-Johnsons syndrom og toksisk epidermal nekrolyse.
Capecitabine can induce severe skin reactions such as Stevens-Johnson syndrome and Toxic Epidermal Necrolysis.
Toksicitet, som skyldes administration af capecitabin, kan behandles symptomatisk og/eller med modifikation af capecitabin-dosis (afbrydelse af behandlingen eller reduktion af dosis).
Toxicity due to capecitabine administration may be managed by symptomatic treatment and/or modification of the dose (treatment interruption or dose reduction).
Desuden anvendes Capecitabine medac til forebyggelse af ny optræden af tyktarmskræft efter fuldstændig fjernelse af svulsten ved operation.
Furthermore, Capecitabine medac is used to prevent new occurrence of colon cancer after complete removal of the tumour by surgery.
Dosisreduktion af capecitabin nedsætter den systemiske eksponering for 5-FU mere end svarende til dosisproportionaliteten på grund af den aktive metabolits non-lineære farmakokinetik.
Capecitabine dose reduction decreases systemic exposure to 5-FU more than dose-proportionally, due to non--linear pharmacokinetics for the active metabolite.
Hypo- eller hyperkalcæmi
Hypo- or hypercalcaemia
Der er set interaktion mellem allopurinol og 5-FU med mulig nedsat effekt af 5-FU.
Interactions with allopurinol have been observed for 5-FU; with possible decreased efficacy of 5-FU.
- ved 2. forekomst
-2nd appearance
Da sikkerheds- og effektdata er baseret på administration sammen med maden, anbefales det at tage capecitabin sammen med et måltid.
Since current safety and efficacy data are based upon administration with food, it is recommended that capecitabine be administered with food.
Tabel 7 Nøgleresultaterne for effekt af non-inferioritetsanalysen af studie NO16966
Table 7 Key efficacy results for the non-inferiority analysis of study NO16966
Efter grad 3-HFS skal dosis af capecitabine sættes ned.
Following grade 3 HFS, subsequent doses of capecitabine should be decreased.
Der er ingen tilgængelige data vedrørende leverinsufficiens på grund af cirrhose eller hepatitis.
No information is available on hepatic impairment due to cirrhosis or hepatitis.
Den poolede analyse omfatter 3.097 patienter, som blev behandlet med regimer, som indeholdt capecitabin, og 3.074 patienter, som blev behandlet med regimer, som indeholdt 5-FU.
The pooled analysis includes 3,097 patients treated with capecitabine-containing regimens and 3,074 patients treated with 5-FU-containing regimens.
De pivotale capecitabin-studier inkluderede kun kvinder i den fertile alder og mænd, hvis de indgik i en aftale om at anvende en egnet præventionsmetode for at undgå graviditet under studiet og i en passende periode efter studiet.
The capecitabine pivotal studies included females of childbearing potential and males only if they agreed to use an acceptable method of birth control to avoid pregnancy for the duration of the study and for a reasonable period thereafter.
Brug af Capecitabine medac sammen med mad og drikke Du skal tage Capecitabine medac senest 30 minutter efter et måltid.
Capecitabine medac with food and drink You should take Capecitabine medac no later than 30 minutes after meals.
Parameter: Samlet overlevelse EPP ITT *EPP=egnet patientpopulation; **ITT=intent-to-treat-population
EPP ITT *EPP = eligible patient population; **ITT = intent-to-treat population.
Humane plasmaundersøgelser in vitro har vist, at capecitabin, 5′ DFCR, 5′ DFUR og 5-FU er hhv. 54 %, 10 %, 62 % og 10 % bundet til protein, hovedsageligt til albumin.
In vitro human plasma studies have determined that capecitabine, 5'-DFCR, 5'-DFUR and 5-FU are 54 %, 10 %, 62 % and 10 % protein bound, mainly to albumin.
Capecitabine medac fås i blistere (aluminium-aluminium eller PVC/PVdC-aluminium).
Capecitabine medac is available in blisters (Aluminium-Aluminium or PVC/PVdC-Aluminium).
Patienterne blev randomiseret til enten at få FOLFIRI plus bevacizumab (arm-A, n = 167) eller XELIRI plus bevacizumab (arm-B, n = 166).
Patients were randomised to receive either FOLFIRI plus bevacizumab (Arm-A, n = 167) or XELIRI plus bevacizumab (Arm-B, n-166).
For termer markeret med ”+” er hyppigheden baseret på bivirkninger af grad 3-4.
For terms marked with a “+”, the frequency count was based on grade 3 - 4 ADRs.
Du skal ikke tage den glemte dosis.
Do not take the missed dose at all.
Effektdata er baseret på en median observationstid på 59 måneder for samlet overlevelse og 57 måneder for sygdomsfri overlevelse.
The efficacy data is based on a median observation time of 59 months for OS and 57 months for DFS.
Capecitabine medac tilhører en gruppe lægemidler, som kaldes “cytostatika”, som standser væksten af kræftceller.
Capecitabine medac belongs to the group of medicines called "cytostatic medicines", which stop the growth of cancer cells.
• smerter eller ændret/unormal følelse i munden, smerter i kæben
• pain or altered/abnormal sensation in the mouth, pain in the jaw
Hvis du har taget for mange Capecitabine medac-tabletter Hvis du har taget for mange Capecitabine medac-tabletter, skal du kontakte din læge hurtigst muligt, før du tager næste dosis.
If you take more Capecitabine medac than you should If you take more Capecitabine medac than you should, contact your doctor as soon as possible before taking the next dose.
Der var en mindre stigning i plasmakoncentrationerne af capecitabin og en af metabolitterne 5'-deoxy-5-fluorocytidin (5'-DFCR), men ingen virkning på de 3 hovedmetabolitter 5'-deoxy-5-fluorouridin (5'-DFUR), 5-FU og α-fluoro-β-alanin (FBAL).
There was a small increase in plasma concentrations of capecitabine and one metabolite 5'-deoxy-5-fluorocytidine (5'-DFCR); there was no effect on the 3 major metabolites: 5'-deoxy-5-fluorouridine (5'-DFUR), 5-FU and α-fluoro-β-alanine (FBAL).
Oxaliplatin på dag 1, hver 3. uge capecitabin oral to gange daglig i 2 uger (efterfulgt af 1 uge uden behandling)
Oxaliplatin on Day 1, every 3 weeks capecitabine oral twice daily for 2 weeks (followed by 1 week off- treatment)
Capecitabin er et non-cytotoksisk fluorpyrimidincarbamat, som virker som en oral administreret prækursor for det cytotoksiske 5-FU.
Capecitabine is a non-cytotoxic fluoropyrimidine carbamate, which functions as an orally administered precursor of the cytotoxic moiety 5-FU.
Enzymerne, som er involverede i den katalytiske aktivering, findes i tumorvæv, men også i normalt væv, om end i lavere koncentrationer.
The enzymes involved in the catalytic activation are found in tumour tissues but also in normal tissues, albeit usually at lower levels.
I humane cancerxenotransplantationsmodeller har capecitabin vist en synergistisk effekt i kombination med docetaxel, som kan være relateret til docetaxels opregulering af ThyPase.
In human cancer xenograft models capecitabine demonstrated a synergistic effect in combination with docetaxel, which may be related to the upregulation of ThyPase by docetaxel.
Studiet indeholdte to dele: En initial 2-arms del, i hvilken 634 patienter blev randomiseret i to forskellige behandlingsgrupper, inkluderende XELOX eller FOLFOX-4, og efterfølgende 2*2 design, i hvilken 1.401 patienter blev randomiseret til 4 forskellige behandlingsgrupper, inkluderende XELOX plus placebo, FOLFOX-4 plus placebo, XELOX plus bevacizumab og FOLFOX-4 plus bevacizumab.
The study contained two parts: an initial 2-arm part in which 634 patients were randomised to two different treatment groups, including XELOX or FOLFOX-4, and a subsequent 2x2 factorial part in which 1,401 patients were randomised to four different treatment groups, including XELOX plus placebo, FOLFOX-4 plus placebo, XELOX plus bevacizumab, and FOLFOX-4 plus bevacizumab.
Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. filmovertrukket tablet, dvs. den er i det væsentlige natrium-fri.
This medicinal product contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially ‘sodium-free'.
Kun når det er optaget i kroppen, ændres det til et aktivt anti-cancer stof (fortrinsvis i svulstvæv).
Only after being absorbed by the body is it changed into an active anti-cancer medicine (more in tumour tissue than in normal tissue).
• øget svedtendens, svedeture om natten
• sweating, night sweats
• til 1. linjebehandling af fremskreden ventrikelkræft i kombination med et platinbaseret regime (se pkt.
• for first-line treatment of advanced gastric cancer in combination with a platinum based regimen (see section 5.1).
I henhold til immunohistokemiske studier synes ThyPase hovedsagelig lokaliseret i stromale tumorceller.
According to immunohistochemical studies, ThyPase appears to be in large part localised in tumour stromal cells.
Desuden indtraf der i en 13 ugers undersøgelse atrofiske og degenerative forandringer i reproduktionsorganerne hos hanmus; forandringerne var dog reversible efter en stoffri periode (se pkt.
In addition, during a 13-week study, atrophic and degenerative changes occurred in reproductive organs of male mice; however these effects were reversible after a drug-free period (see section 4.6).
Capecitabin skal seponeres permanent hos patienter, der oplever en alvorlig hudreaktion under behandlingen.
Capecitabine should be permanently discontinued in patients who experience a severe skin reaction during treatment.
• usædvanlig blødning fra skeden
• unusual bleeding from the vagina
• problemer med leverfunktionen (målt i blodprøver) og øget blodbilirubin (udskilt i leveren)
• problems with liver function (seen in blood tests) and increased blood bilirubin (excreted by the liver)
Køn, tilstedeværelse eller fravær af levermetastaser ved baseline, Karnofsky Performance Status, total bilirubin, serum-albumin, aspartataminotransferase (ASAT) og alaninaminotransferase (ALAT) havde ingen statistisk signifikant effekt på farmakokinetikken af 5'-DFUR, 5-FU og FBAL.
Gender, presence or absence of liver metastasis at baseline, Karnofsky Performance Status, total bilirubin, serum albumin, aspartate-aminotransferase (ASAT) and alanine-aminotransferase (ALAT) had no statistically significant effect on the pharmacokinetics of 5'-DFUR, 5-FU and FBAL.
Baseret på populationsfarmakokinetiske analyser, som omfattede patienter i mange aldre (27 - 86 år), og som omfattede 234 (46 %) patienter, som var mindst 65 år, spillede alderen ingen rolle for farmakokinetikken af 5'-DFUR og 5-FU.
Based on the population pharmacokinetic analysis, which included patients with a wide range of ages (27 to 86 years) and included 234 (46 %) patients greater or equal to 65, age has no influence on the pharmacokinetics of 5'-DFUR and 5-FU.
HFS også kendt som hand-foot-hudreaktion, palmo-plantar erytrodysæstesi eller kemoterapiinduceret akralt erytem.
HFS also known as hand-foot skin reaction or palmar-plantar erythrodysesthesia or chemotherapy induced acral erythema.
Der bør udvises forsigtighed, når capecitabin administreres samtidig med 2C9substrater (fx phenytoin).
Care should be exercised when capecitabine is co-administered with 2C9 substrates (e.g. phenytoin).
Legemsoverfladeareal (m²)
Body surface area (m²)
Samlet responsrate var 49 % i XELIRI-armen og 48 % i FOLFIRI-armen (p = 0,76).
Overall response rate was 49 % in the XELIRI and 48 % in the FOLFIRI arm (p = 0.76).
Kutan lupus erythematosus (sjælden), Alvorlige hudreaktioner såsom
Cutaneous lupus erythematosus (rare), Severe skin reactions such as
• strålebehandling og visse lægemidler mod kræft (folinsyre, oxaliplatin, bevacizumab, cisplatin,
• radiotherapy and certain medicines used to treat cancer (folinic acid, oxaliplatin, bevacizumab,
• talebesvær, nedsat hukommelse, nedsat evne til at koordinere bevægelser, balanceforstyrrelser,
• difficulty speaking, impaired memory, loss of movement coordination, balance disorder,
Tabel 4 anfører de bivirkninger, der er forbundet med anvendelsen af capecitabin-monoterapi baseret på en samlet analyse af sikkerhedsdata fra 3 store studier med flere end 1.900 patienter (studierne M66001, SO14695 og SO14796).
Table 4 lists ADRs associated with the use of capecitabine monotherapy based on a pooled analysis of safety data from three major studies including over 1,900 patients (studies M66001, SO14695, and SO14796).
Der er ingen data om capecitabin og påvirkning af fertilitet.
There is no data on capecitabine and impact on fertility.
Ved dehydrering af grad 2 (eller højere) bør behandlingen med capecitabin straks seponeres, og dehydreringen korrigeres.
If grade 2 (or higher) dehydration occurs, capecitabine treatment should be immediately interrupted and the dehydration corrected.
Der er nogen evidens for, at dexpanthenol er virksomt som profylakse mod HFS hos patienter, der behandles med capecitabin.
There is some evidence that dexpanthenol is effective for HFS prophylaxis in patients treated with capecitabine.
Stevens-Johnsons syndrom og toksisk epidermal nekrolyse (meget sjælden) (se pkt.
Stevens-Johnson Syndrome and toxic Epidermal Necrolysis (very rare) (see section 4.4)
• Patienter med svær nyreinsufficiens (creatininclearance under 30 ml/min),
• In patients with severe renal impairment (creatinine clearance below 30 ml/min),
Meget almindelig Alle grader
Very common All grades
• visse typer af hjerterytmeforstyrrelser (herunder såkaldt ventrikulær fibrillation, torsade de pointes og bradykardi)
• certain types of arrhythmia (including ventricular fibrillation, torsade de pointes, and bradycardia)
Abdominal ubehag
Abdominal discomfort
Se også interaktion med antikoagulerende midler af coumarintypen nedenfor samt under pkt.
See also interaction with coumarin-derivative anticoagulants below, and section 4.4.
Da dette lægemiddel indeholder vandfri lactose som hjælpestof, bør patienter med arvelig galactoseintolerans, en særlig form for hereditær lactasemangel (Lapp Lactase deficiency) eller glucose/galactosemalabsorption ikke anvende denne medicin.
As this medicinal product contains anhydrous lactose as an excipient, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
For patienter med delvis DPD-mangel (fx med heterozygote mutationer i DPYD-genet), og hvor fordelene af capecitabin anses for at opveje risikoen (under hensyntagen til egnetheden af et alternativt ikke-fluorpyrimidin kemoterapeutisk regime), gælder, at de skal behandles med yderste forsigtighed og hyppig monitorering med dosisjustering i henhold til toksicitet.
For patients with partial DPD deficiency (such as those with heterozygous mutations in the DPYD gene) and where the benefits of capecitabine are considered to outweigh the risks (taking into account the suitability of an alternative non-fluoropyrimidine chemotherapeutic regimen), these patients must be treated with extreme caution and frequent monitoring with dose adjustment according to toxicity.
ENTYDIG IDENTIFIKATOR - 2D-STREGKODE <Der er anført en 2D-stregkode, som indeholder en entydig identifikator.>
UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
Efter oral administration af 825 mg/m² capecitabin to gange dagligt i 14 dage, havde patienter af japansk oprindelse (n = 18) omkring 36 % lavere Cmax og 24 % lavere AUC for capecitabin end patienter af kaukasisk oprindelse (n = 22).
Following oral administration of 825 mg/m² capecitabine twice daily for 14 days, Japanese patients (n = 18) had about 36 % lower Cmax and 24 % lower AUC for capecitabine than Caucasian patients (n = 22).
Interferon-alfa
Interferon alpha
Capecitabin var fri for hepatisk og CNS-toksicitet.
Capecitabine was devoid of hepatic and CNS toxicities.
• Stevens-Johnsons syndrom: hvis du oplever smertefuldt rødt eller lilla udslæt, der spreder sig og danner blistre og/eller andre læsioner, der opstår i slimhinderne (fx mund eller læber), især hvis du tidligere har været følsom over for lys, haft infektioner i luftvejene (fx bronkitis) og/eller feber.
• Stevens-Johnson syndrome: if you experience painful red or purplish rash that spreads and blisters and/or other lesions begin to appear in the mucous membrane (e.g. mouth and lips), in particular if you had before light sensitivity, infections of the respiratory system (e.g. bronchitis) and/or fever.
Sikkerhedsprofilen for capecitabin-monoterapi i populationerne med metastatisk brystkræft, metastatisk kolorektalkræft og adjuverende kolonkræft er sammenlignelig.
The safety profiles of capecitabine monotherapy for the metastatic breast cancer, metastatic colorectal cancer and adjuvant colon cancer populations are comparable.
Patienter, som ved baseline har et neutrofiltal < 1,5 x 109/l og/eller et trombocyttal < 100 x 109/l, bør ikke behandles med capecitabin.
Patients with baseline neutrophil counts of < 1.5 x 109/L and/or thrombocyte counts of < 100 x 109/L should not be treated with capecitabine.
Hvis der ikke ses toksicitet hos patienter ≥ 60 år, som behandles med en nedsat initial capecitabin-dosis i kombination med docetaxel, kan capecitabin-dosis med forsigtighed øges til 1.250 mg/m² to gange dagligt.
If no toxicity is observed in patients ≥ 60 years of age treated with a reduced capecitabine starting dose in combination with docetaxel, the dose of capecitabine may be cautiously escalated to 1,250 mg/m² twice daily.
28 filmovertrukne tabletter 30 filmovertrukne tabletter 56 filmovertrukne tabletter 60 filmovertrukne tabletter 84 filmovertrukne tabletter 112 filmovertrukne tabletter 120 filmovertrukne tabletter
28 film-coated tablets 30 film-coated tablets 56 film-coated tablets 60 film-coated tablets 84 film-coated tablets 112 film-coated tablets 120 film-coated tablets
Hver pakning indeholder 28, 30, 56, 60, 84, 112 eller 120 filmovertrukne tabletter.
Each pack contains 28, 30, 56, 60, 84, 112, or 120 film-coated tablets.