natgillin/translations-raw huggingface dataset:
Da antikolinergika hovedsagelig elimineres via biotransformation, er den potentielle risiko for interaktion begrænset, selvom interaktion med antikolinergika ikke er blevet undersøgt.
As anticholinergics are mainly eliminated by biotransformation, the potential for an interaction is limited, although an interaction with anticholinergics has not been investigated.
Der er ingen pharmakokinetisk interaktion mellem selegilin og levodopa.
There is no pharmacokinetic interaction with selegiline and levodopa.
34%, antagelig ved hæmning af den kationiske sekretionstransportsystem i de renale tubuli.
Therefore, medicinal products
Reduktion
4 that are inhibitors of this active renal elimination pathway or are eliminated by this pathway, such as cimetidine and amantadine, may interact with pramipexole resulting in reduced clearance of either or both medicinal products.
4 af pramipexols dosis bør overvejes i de tilfælde, hvor disse lægemidler administreres samtidigt med Oprymea.
Reduction of the pramipexole dose should be considered when these medicinal products are administered concomitantly.
Når Oprymea gives i kombination med levodopa, anbefales det at reducere doseringen af levodopa og at holde doseringen af andre antiparkinson- midler konstant, mens doseringen af Oprymea øges.
When Oprymea is given in combination with levodopa, it is recommended that the dosage of levodopa is reduced and the dosage of other anti-parkinsonian medicinal products is kept constant while increasing the dose of Oprymea.
Som følge af mulig additiv effekt bør der udvises forsigtighed, hvis patienten tager anden sedativ medicin eller alkohol i kombination med pramipexol.
Because of possible additive effects, caution should be advised when patients are taking other sedating medicinal products or alcohol in combination with pramipexole.
4. 4), f. eks. hvis der kan forventes en antagonistisk virkning.
Coadministration of antipsychotic medicinal products with pramipexole should be avoided (see section 4.4), e. g. if antagonistic effects can be expected.
Effekten på graviditet og amning er ikke blevet undersøgt på mennesker.
The effect on pregnancy and lactation has not been investigated in humans.
Oprymea bør ikke bruges under graviditet, medmindre det er strengt nødvendigt, f. eks. hvis den potentielle gavn retfærdiggør den potentielle risiko for fostret.
Oprymea should not be used during pregnancy unless clearly necessary, i. e. if the potential benefit justifies the potential risk to the foetus.
Da behandling med pramipexol hæmmer sekretionen af prolaktin hos mennesker, forventes også hæmning af laktationen.
As pramipexole treatment inhibits secretion of prolactin in humans, inhibition of lactation is expected.
Udskillelsen af pramipexol i modermælk hos kvinder er ikke blevet undersøgt.
The excretion of pramipexole into breast milk has not been studied in women.
Hos rotter var koncentrationen af det aktive stof højere i modermælk end i plasma.
In rats, the concentration of active substance-related radioactivity was higher in breast milk than in plasma.
Som følge af manglende data fra mennesker bør Oprymea ikke anvendes af ammende kvinder.
In the absence of human data, Oprymea should not be used during breast-feeding.
Hvis det ikke er muligt at undgå brug af Oprymea, så bør amningen ophøre.
However, if its use is unavoidable, breast-feeding should be discontinued.
4. 4, 4. 5 og 4. 8).
Patients being treated with Oprymea and presenting with somnolence and/ or sudden sleep episodes must be informed to refrain from driving or engaging in activities where impaired alertness may put themselves or others at risk of serious injury or death (e. g. operating machines) until such recurrent episodes and somnolence have resolved (see also sections 4.4, 4.5, and 4.8).
Abnorme drømme, konfusion, forstoppelse, vrangforestilling, svimmelhed, dyskinesi, træthed, hallucinationer, hovedpine, hyperkinesi, hypotension, overspisning (bulimi- lignende tilstand, uhæmmet madindtagelse), søvnløshed, libidoforstyrrelser, kvalme, perifert ødem, paranoia, ludomani, hyperseksualitet og anden abnorm adfærd, somnolens, vægtøgning, pludseligt opstået søvnepisoder, kløe, udslæt og anden overfølsomhed.
The following adverse reactions are expected under the use of Oprymea: abnormal dreams, confusion, constipation, delusion, dizziness, dyskinesia, fatigue, hallucinations, headache, hyperkinesia, hypotension, increased eating (binge eating, hyperphagia), insomnia, libido disorders, nausea, peripheral oedema, paranoia, pathological gambling, hypersexuality and other abnormal behaviour; somnolence, weight increase, sudden onset of sleep; pruritus and rash and other hypersensitivity.
Baseret på analysen af poolede placebo- kontrollerede kliniske forsøg, der i alt omfattede 1923 patienter i behandling med pramipexol og 1354 patienter i placebobehandling, blev bivirkninger hyppigt rapporteret for begge grupper.
Based on the analysis of pooled placebo-controlled trials, comprising a total of 1,923 patients on pramipexole and 1,354 patients on placebo, adverse drug reactions were frequently reported for both groups.
63% af patienterne i pramipexolbehandling og 52% af patienterne i placebobehandling rapporterede mindst en bivirkning
63% of patients on pramipexole and 52% of patients on placebo reported at least one adverse drug reaction.
De mest almindelige (≥5%) rapporterede bivirkninger hos patienter med Parkinsons sygdom, som oftere blev set ved behandling med pramipexol end med placebo var: kvalme, dyskinesi, hypotension, svimmelhed, somnolens, søvnløshed, forstoppelse, hallucinationer, hovedpine og træthed.
The most commonly (≥ reported adverse reactions in patients with Parkinson’ s disease more 5%) frequent with pramipexole treatment than with placebo were nausea, dyskinesia, hypotension, dizziness, somnolence, insomnia, constipation, hallucination, headache and fatigue.
Forekomsten af somnolens er forøget ved doser højere end 1, 5 mg/ dag (se pkt.
The incidence of somnolence is increased at doses higher than 1.5 mg/ day (see section 4.2).
4. 2).
More frequent adverse drug
En mere hyppig bivirkning i kombination med levodopa var dyskinesi.
5 reaction in combination with levodopa was dyskinesia.
5 De mest almindelige (≥5%) rapporterede bivirkninger hos patienter med andre indikationer, behandlet med pramipexol var: kvalme, hovedpine, svimmelhed og træthed.
with pramipexole were nausea, headache, dizziness and fatigue.
Kvalme og træthed blev oftere rapporteret hos kvindelige patienter (henholdsvis 20, 8% og 10, 5%) sammenlignet med mandlige patienter (henholdsvis 6, 7% og 7, 3%).
Nausea and fatigue were more often reported in female patients (20.8% and 10.5%, respectively) compared to males (6.7% and 7.3%, respectively).
Tabel 1 og 2 viser hyppigheden af bivirkninger fra placebokontrollerede kliniske studier.
Tables 1 and 2 display the frequency of adverse reactions from placebo-controlled clinical trials.
Bivirkningerne, der er rapporteret i disse tabeller, er de, der forekom hos 1% eller mere af patienterne, som blev behandlet med pramipexol, og som blev rapporteret signifikant hyppigere hos de patienter, som blev behandlet med pramipexol end hos patienter i placebobehandling, eller hvor bivirkningen blev vurderet som værende klinisk relevant.
The adverse reactions reported in these tables are those events that occurred in 1% or more of patients treated with pramipexole and were reported significantly more often in patients taking pramipexole than placebo, or where the event was considered clinically relevant.
Størstedelen af de almindelige bivirkninger var dog milde til moderate, de startede som regel tidligt i behandlingen, og forsvandt for det meste ved fortsat behandling.
However, the majority of common adverse reactions were mild to moderate, they usually start early in therapy, and most tended to disappear even as therapy was continued.
Meget almindelige bivirkninger (≥1/ 10) Systemorganklasse
Very common Adverse Reactions (≥ 1/ 10) System organ class
Svimmelhed Dyskinesi
Dizziness Dyskinesia
Mave- tarmkanalen Vaskulære sygdomme
Gastrointestinal disorders Vascular disorders
Kvalme Hypotension
Nausea Hypotension
17, 2 12, 6
17.2 12.6
Almindelige bivirkninger (≥1/ 100 til < 1/ 10) Pramipexol Systemorganklasse
Common Adverse Reactions (≥ 1/ 100 to < 1/ 10) System organ class
N = 1923 (%)
Pramipexole N= 1,923 (%)
Abnorme drømme Konfusion Hallucinationer Søvnløshed
Abnormal dreams Confusional state Hallucinations Insomnia
3, 5 3, 0 6, 6 8, 2
3.5 3.0 6.6 8.2
Somnolens Hovedpine
Somnolence Headache
Forstoppelse Træthed Perifert ødem
General disorders and administration site conditions
5, 5 6, 1 1, 9
Fatigue
Pramipexol er forbundet med somnolens (8, 6%), og er i usædvanlige tilfælde blevet forbundet med overdreven somnolens i dagtimerne og pludseligt opståede søvnepisoder (0, 1%).
Pramipexole is associated with somnolence (8.6%) and has been associated uncommonly with excessive daytime somnolence and sudden sleep onset episodes (0.1%).
Pramipexol kan forbindes med libidosygdomme (øget (0, 1%) eller nedsat (0, 4%)).
Pramipexole may be associated with libido disorders (increased (0.1%) or decreased (0.4%)).
Disse tilstande er sædvanligvis reversible ved seponering.
Patients treated with dopamine agonists for Parkinson’ s disease, including pramipexole, especially at high doses, have been reported as exhibiting signs of pathological gambling, increase libido and hypersexuality, generally reversible upon treatment discontinuation.
De forventede bivirkninger vil kunne relateres til den farmakodynamiske profil for en dopaminagonist herunder kvalme, opkastning, hyperkinesi, hallucinationer, agitation og hypotension.
The expected adverse events would be those related to the pharmacodynamic profile of a dopamine agonist, including nausea, vomiting, hyperkinesia, hallucinations, agitation and hypotension.
Der er intet kendt antidot ved overdosering af en dopaminagonist.
There is no established antidote for overdose 6 of a dopamine agonist.
Ved tegn på stimulation af centralnervesystemet kan et neuroleptikum være indiceret.
If signs of central nervous system stimulation are present, a neuroleptic agent may be indicated.
N04BC05.
N04BC05.
Det har fuld intrinsisk aktivitet.
Pramipexole is a dopamine agonist that binds with high selectivity and specificity to the D2 subfamily of dopamine receptors of which it has a preferential affinity to D 3 receptors, and has full intrinsic activity.
Pramipexol letter det parkinsonistiske motoriske underskud ved stimulering af dopaminreceptorer i striatum.
Pramipexole alleviates Parkinsonian motor deficits by stimulation of dopamine receptors in the striatum.
Dyreforsøg har vist, at pramipexol hæmmer dopamins syntese, frigørelse og omsætning.
Animal studies have shown that pramipexole inhibits dopamine synthesis, release, and turnover.
Kontrollerede kliniske undersøgelser inkluderende ca.
In patients pramipexole alleviates signs and symptoms of idiopathic Parkinson 's disease.
Ud af disse var ca.
Controlled clinical trials included approximately 2100 patients of Hoehn and Yahr stages I – IV.
900 på mere fremskredne stadier, og fik samtidig levodopaterapi og havde motoriske komplikationer.
Out of these, approximately 900 were in more advanced stages, received concomitant levodopa therapy, and suffered from motor complications.
6 måneder.
In early and advanced Parkinson’ s disease, efficacy of pramipexole in the controlled clinical trials was maintained for approximately six months.
I fortsatte, åbne undersøgelser over mere end tre år var der ikke tegn på aftagende effekt.
In open continuation trials lasting for more than three years there were no signs of decreasing efficacy.
Den samlede incidens af hallucinationer og somnolens var generelt højere i fasen med gradvis dosisøgning hos pramipexolgruppen.
The overall incidence of hallucinations and somnolence was generally higher in the escalation phase with the pramipexole group.
Der var dog ingen signifikant forskel i vedligeholdelsesfasen.
However there was no significant difference during the maintenance phase.
Pramipexol udviser lineær kinetik og kun en lille interindividuel variation i plasmaniveau.
Pramipexole shows linear kinetics and a small inter-patient variation of plasma levels.
Den væsentligste eliminationsvej er renal udskillelse af uomdannet pramipexol.
Renal excretion of unchanged pramipexole is the major route of elimination.
90% af en 14C - mærket dosis udskilles via nyrerne, mens mindre end 2% findes i fæces.
Approximately 90% of 14 C-labelled dose is excreted through the kidneys while less than 2% is found in the faeces.
Eliminations - halveringstiden (t ½) varierer mellem 8 timer hos yngre og 12 timer hos ældre.
The elimination half-life (t½) varies from 8 hours in the young to 12 hours in the elderly.
7 hovedsagelig involverer CNS og det kvindelige reproduktionssyst em, antagelig somresultat af en overdreven farmakodynamisk virkning af pramipexol.
Repeated dose toxicity studies showed that pramipexole exerted functional effects, mainly involving the CNS and female reproductive system, and probably resulting from an exaggerated pharmacodynamic effect of pramipexole.
Fald i det diastoliske og systoliske blodtryk og hjerterytmen blev fundet hos minigrise, og en tendens til en hypotensiv virkning blev erkendt hos aber.
Decreases in diastolic and systolic pressure and heart rate were noted in the mini pig, and a tendency to an hypotensive effect was discerned in the monkey.
De potentielle virkninger af pramipexol på den reproduktive funktion er blevet undersøgt i rotter og kaniner.
The potential effects of pramipexole on reproductive function have been investigated in rats and rabbits.
Pramipexol var ikke teratogen i rotter og kaniner, men var embryotoksisk hos rotter ved maternotoksiske doser.
Pramipexole was not teratogenic in rats and rabbits but was embryotoxic in the rat at maternally toxic doses.
På grund af de valgte dyrearter og det begrænsede antal undersøgte parametre er pramipexols bivirkninger i forbindelse med graviditet og mandlig fertilitet ikke fuldt belyst.
Due to the selection of animal species and the limited parameters investigated, the adverse effects of pramipexole on pregnancy and male fertility have not been fully elucidated.
I et karcinogenstudie udviklede hanrotter Leydig- cellehyperplasi og adenomer, pga. pramipexols prolaktinhæmmende effekt.
In a carcinogenicity study, male rats developed Leydig cell hyperplasia and adenomas, explained by the prolactin-inhibiting effect of pramipexole.
Samme studie viste tillige hos albinorotter, at doser på 2 mg/ kg (salt) pramipexol og derover kunne associeres med retinal degeneration.
The same study also showed that, at doses of 2 mg/ kg (of salt) and higher, pramipexole was associated with retinal degeneration in albino rats.
Mannitol Majsstivelse Pregelatineret majsstivelse Povidon K25 Kolloid, vandfri silica Magnesiumstearat
Mannitol Maize starch Pregelatinised maize starch Povidone K25 Colloidal anhydrous silica Magnesium stearate
Blisterpakning (Aluminium/ aluminium folie):
Blister pack (Al/ Al foil):
20, 30, 60, 90 eller 100 tabletter.
20, 30, 60, 90 or 100 tablets.
8 8501 Novo mesto, Slovenien
KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
20 tabletter:
20 tablets:
EU/ 1/ 08/ 469/ 001 30 tabletter:
EU/ 1/ 08/ 469/ 001 30 tablets:
EU/ 1/ 08/ 469/ 002 60 tabletter:
EU/ 1/ 08/ 469/ 002 60 tablets:
EU/ 1/ 08/ 469/ 003 90 tabletter:
EU/ 1/ 08/ 469/ 003 90 tablets:
EU/ 1/ 08/ 469/ 004 100 tabletter:
EU/ 1/ 08/ 469/ 004 100 tablets:
Oprymea 0, 18 mg tabletter
Oprymea 0.18 mg tablets
Hver tablet indeholder 0, 18 mg pramipexolbase (som 0, 25 mg pramipexol dihydrochloridmonohydrat).
Each tablet contains 0.18 mg pramipexole base (as 0.25 mg pramipexole dihydrochloride monohydrate).
Hvid, oval, med skrå kanter, delekærv på begge sider og præget med ” P7 ” på begge halvdele af den ene side af tabletten.
0.18 mg: white, oval, with bevelled edges, both sides scored, with imprint "P7" on both halves of one side of the tablet.
4. 8)
10 However, it should be noted that the incidence of somnolence is increased at doses higher than 1.5 mg/ day (see section 4.8).
Hos patienter med kreatininclearance mindre end 20 ml/ min. bør den daglige dosis af Oprymea gives som en enkeltdosis begyndende med 0, 088 mg base (0, 125 mg salt) / døgn.
In patients with a creatinine clearance less than 20 ml/ min, the daily dose of Oprymea shou ld be administered in a single dose, starting at 0.088 mg of base (0.125 mg of salt) daily.
Ved ordination af Oprymea til en patient med Parkinsons sygdom med nedsat nyrefunktion bør dosis
11 When prescribing Oprymea in a patient with Parkinson’ s disease with renal impairment a reduced dose is suggested in line with section 4.2.
Hallucinationer er kendt som en bivirkning ved behandling med dopaminagonister og levodopa.
Hallucinations are known as a side-effect of treatment with dopamine agonists and levodopa.
34%, antagelig ved hæmning af den kationiske sekretionstransportsystem i de renale tubuli.
Cimetidine reduced the renal clearance of pramipexole by approximately 34%, presumably by inhibition of the cationic secretory transport system of the renal tubules.
Lægemidler, som hæmmer den aktive, renale eliminationsvej eller elimineres via denne vej, såsom cimetidin og amantadin, kan derfor være årsag til
Therefore, medicinal products
12 interaktion med pramipexol, resulterende i reduceret clearance af et eller begge lægemidler.
12 that are inhibitors of this active renal elimination pathway or are eliminated by this pathway, such as cimetidine and amantadine, may interact with pramipex ole resulting in reduced clearance of either or both medicinal products.
Reduktion af pramipexols dosis bør overvejes i de tilfælde, hvor disse lægemidler administreres samtidigt med Oprymea.
Reduction of the pramipexole dose should be considered when these medicinal products are administered concomitantly.
En mere hyppig bivirkning i kombination med levodopa var dyskinesi.
13 reaction in combination with levodopa was dyskinesia.
Hypotension kan forekomme i begyndelsen af behandlingen,
Hypotension may occur at the beginning of treatment, especially if pramipexole is titrated too fast.
13 specielt hvis pramipexol bliver titreret for hurtigt.
5%) reported adverse drug reactions in patients with other indication treated
De mest almindelige (≥5%) rapporterede bivirkninger hos patienter med andre indikationer, behandlet med pramipexol var: kvalme, hovedpine, svimmelhed og træthed.
with pramipexole were nausea, headache, dizziness and fatigue.
Der er intet kendt antidot ved overdosering af en dopaminagonist.
There is no established antidote for overdose 14 of a dopamine agonist.
Det har fuld intrinsisk aktivitet.
Pramipexole is a dopamine agonist that binds with high selectivity and specificity to the D 2 subfamily of dopamine receptors of which it has a preferential affinity to D 3 receptors, and has full intrinsic activity.
Den totale clearance for pramipexol er omkring 500 ml/ min. og den renale clearance er omkring 400 ml/ min.
The total clearance of pramipexole is approximately 500 ml/ min and the renal clearance is approximat ely 400 ml/ min.
Eliminations - halveringstiden (t½) varierer mellem 8 timer hos yngre og 12 timer hos ældre.
The elimination half-life (t½) varies from 8 hours in the young to 12 hours in the elderly.
15 hovedsagelig involverer CNS og det kvindelige reproduktionssystem, antagelig somresultat af en overdreven farmakodynamisk virkning af pramipexol.
Repeated dose toxicity studies showed that pramipexole exerted functional effects, mainly involving the CNS and female reproductive system, and probably resulting from an exaggerated pharmacodynamic effect of pramipexole.
16 8501 Novo mesto, Slovenien
KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
EU/ 1/ 08/ 469/ 006 30 tabletter:
EU/ 1/ 08/ 469/ 006 30 tablets:
EU/ 1/ 08/ 469/ 007 60 tabletter:
EU/ 1/ 08/ 469/ 007 60 tablets:
EU/ 1/ 08/ 469/ 008 90 tabletter:
EU/ 1/ 08/ 469/ 008 90 tablets:
EU/ 1/ 08/ 469/ 009 100 tabletter:
EU/ 1/ 08/ 469/ 009 100 tablets:
Oprymea 0, 35 mg tabletter
Oprymea 0.35 mg tablets
Hver tablet indeholder 0, 35 mg pramipexolbase (som 0, 5 mg pramipexol dihydrochloridmonohydrat).
Each tablet contains 0.35 mg pramipexole base (as 0.5 mg pramipexole dihydrochloride monohydrate).
Hvid, oval, med skrå kanter, delekærv på begge sider og præget med ” P8 ” på begge halvdele af den ene side af tabletten.
0.35 mg: white, oval, with bevelled edges, both sides scored, with imprint "P8" on both halves of one side of the tablet.
4. 8)
18 However, it should be noted that the incidence of somnolence is increased at doses higher than 1.5 mg/ day (see section 4.8).
4. 2.
19 When prescribing Oprymea in a patient with Parkinson’ s disease with renal impairment a reduced dose is suggested in line with section 4.2.
Lægemidler, som hæmmer den aktive, renale
20 Cimetidine reduced the renal clearance of pramipexole by approximately 34%, presumably by inhibition of the cationic secretory transport system of the renal tubules.
20 eliminationsvej eller elimineres via denne vej, såsom cimetidin og amantadin, kan derfor være årsag til interaktion med pramipexol, resulterende i reduceret clearance af et eller begge lægemidler.
Therefore, medicinal products that are inhibitors of this active renal elimination pathway or are eliminated by this pathway, such as cimetidine and amantadine, may interact with pramipexole resulting in reduced clearance of either or both medicinal products.
De mest almindelige (≥5%) rapporterede bivirkninger hos patienter med Parkinsons sygdom, som oftere blev set ved behandling med pramipexol end med placebo var: kvalme, dyskinesi, hypotension, svimmelhed, somnolens, søvnløshed, forstoppelse, hallucinationer, hovedpine og træthed.
The most commonly (≥ reported adverse reactions in patients with Parkinson’ s disease more 5%) frequent with pramipexole treatment than with placebo were nausea, dyskinesia, hypotension,
21 kombination med levodopa var dyskinesi.
21 dizziness, somnolence, insomnia, constipation, hallucination, headache and fatigue.
Der er ingen klinisk erfaring med massiv overdosering.
22 There is no clinical experience with massive overdose.
Der er intet kendt antidot ved overdosering af en dopaminagonist.
There is no established antidote for overdose of a dopamine agonist.
22 Behandling af overdosering kan kræve generel understøttende behandling med udpumpning, intravenøst drop, indgivelse af aktivt kul og elektrokardiografisk overvågning.
Management of the overdose may require general supportive measures, along with gastric lavage, intravenous fluids, administration of activated charcoal and electrocardiogram monitoring.
90% af en 14C - mærket dosis udskilles via nyrerne, mens mindre end 2% findes i fæces.
The total
Den totale clearance for pramipexol er omkring 500 ml/ min. og den renale clearance er omkring 400 ml/ min.
23 clearance of pramipexole is approximately 500 ml/ min and the renal clearance is approximately 400 ml/ min.
23 Toksicitetsstudier med gentagen dosering viser, at pramipexol udøver funktionelle virkninger, som hovedsagelig involverer CNS og det kvindelige reproduktionssystem, antagelig somresultat af en overdreven farmakodynamisk virkning af pramipexol.
Repeated dose toxicity studies showed that pramipexole exerted functional effects, mainly involving the CNS and female reproductive system, and probably resulting from an exaggerated pharmacodynamic effect of pramipexole.
Ikke anvendte lægemidler samt affald heraf bør destrueres i henhold til lokale retningslinjer.
24 Any unused product or waste material should be disposed of in accordance with local requirements.
24 d. d., Novo mesto, Š marješ cesta 6, ka 8501 Novo mesto, Slovenien
KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
EU/ 1/ 08/ 469/ 011 30 tabletter:
EU/ 1/ 08/ 469/ 011 30 tablets:
EU/ 1/ 08/ 469/ 012 60 tabletter:
EU/ 1/ 08/ 469/ 012 60 tablets:
EU/ 1/ 08/ 469/ 013 90 tabletter:
EU/ 1/ 08/ 469/ 013 90 tablets:
EU/ 1/ 08/ 469/ 014 100 tabletter:
EU/ 1/ 08/ 469/ 014 100 tablets:
Oprymea 0, 7 mg tabletter
Oprymea 0.7 mg tablets