natgillin/translations-raw huggingface dataset:
Paroxetin bør alligevel ikke anvendes under amning, medmindre de forventede fordele for moderen berettiger de potentielle risici for spædbarnet.
Abrupt discontinuation should be avoided during pregnancy (see "Withdrawal Symptoms Seen on Discontinuation of Paroxetine", section 4.2 Posology and Method of Administration).
4. 7 Virkninger på evnen til at føre motorkøretøj eller betjene maskiner
Neonates should be observed if maternal use of paroxetine continues into the later stages of pregnancy, particularly the third trimester.
Kliniske erfaringer har vist, at behandling med paroxetin ikke er forbundet med nedsat kognitiv eller psykomotorisk funktion.
The following symptoms may occur in the neonate after maternal paroxetine use in later stages of pregnancy: respiratory distress, cyanosis, apnoea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycaemia, hypertonia, hypotonia, hyperreflexia, tremor, jitteriness, irritability, lethargy, constant crying, somnolence and difficulty in sleeping.
Som med alle psykoaktive lægemidler bør patienterne alligevel advares om, at deres evne til at føre motorkøretøj eller betjene maskiner kan blive forringet.
These symptoms could be due to either serotonergic effects or withdrawal symptoms.
Selvom paroxetin ikke yderligere forringer de mentale eller motoriske evner, som skyldes alkohol, frarådes samtidig brug af paroxetin og alkohol.
In a majority of instances the complications begin immediately or soon (< 24 hours) after delivery.
Hyppigheden defineres som følger: meget almindelig (≥ 1/ 10), almindelig (≥ 1/ 100, < 1/ 10), usædvanlig (≥ 1/ 1. 000, < 1/ 100), sjælden (≥ 1/ 10. 000, < 1/ 1. 000), meget sjælden (< 1/ 10. 000), herunder isolerede rapporter.
Animal studies showed reproductive toxicity, but did not indicate direct harmful effects with respect to pregnancy, embryonal/ foetal development, parturition or postnatal development (see Section 5.3 Preclinical Safety Data).
Lidelser i blod og lymfe Usædvanlig:
Lactation Small amounts of paroxetine are excreted into breast milk.
Trombocytopeni.
In published studies, serum concentrations in breast-fed infants were undetectable (< 2 ng/ ml) or very low (< 4 ng/ ml).
Immunsystemforstyrrelser Meget sjælden:
No signs of drug effects were observed in these infants.
Allergiske reaktioner (herunder urticaria og angioødem).
Nevertheless, paroxetine should not be used during lactation unless the expected benefits to the mother justify the potential risks for the infant.
Endokrine lidelser Meget sjælden:
4.7 Effects on Ability to Drive and Use Machines
Nedsat appetit.
Clinical experience has shown that therapy with paroxetine is not associated with impairment of cognitive or psychomotor function.
Hyponatriæmi.
However, as with all psychoactive drugs, patients should be cautioned about their ability to drive a car and operate machinery.
Hyponatriæmi er fortrinsvis rapporteret hos ældre patienter og undertiden på grund af SIADH.
Although paroxetine does not increase the mental and motor skill impairments caused by alcohol, the concomitant use of paroxetine and alcohol is not advised.
Psykiatriske lidelser Almindelig:
4.8 Undesirable Effects
Usædvanlig:
Some of the adverse drug reactions listed below may decrease in intensity and frequency with continued treatment and do not generally lead to cessation of therapy.
Sjælden:
Adverse drug reactions are listed below by system organ class and frequency.
Disse symptomer kan også skyldes den underliggende sygdom.
Frequencies are defined as: very common (≥ 1/ 10), common (≥ 1/ 100, < 1/ 10), uncommon (≥ 1/ 1,000, < 1/ 100), rare (≥ 1/ 10,000, < 1/ 1,000), very rare (< 1/ 10,000), including isolated reports.
CHMP/ 187488/ 2004 Usædvanlig:
CHMP/ 187488/ 2004 Blood and lymphatic system disorders
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Meget sjælden:
Very rare: thrombocytopenia.
Lidelser i øjne Almindelig:
skin and mucous membranes (mostly
Sløret syn Meget sjælden:
Immune system disorders
Sinus takykardi.
Very rare: allergic reactions (including urticaria and angioedema).
Bradycardi.
Endocrine disorders Very rare: syndrome of inappropriate anti-diuretic hormone secretion (SIADH).
Vaskulære lidelser.
Metabolism and nutrition disorders Common: decreased appetite.
Usædvanlig:
Rare: hyponatraemia.
Forbigående stigning eller fald i blodtryk er rapporteret efter behandling med paroxetin, oftest hos patienter med forudgående hypertension eller angst.
Hyponatraemia has been reported predominantly in elderly patients and is sometimes due to syndrome of inappropriate anti-diuretic hormone secretion (SIADH).
Gastrointestinale lidelser Meget almindelig:
Psychiatric disorders Common: somnolence, insomnia.
Almindelig:
Uncommon: confusion, hallucinations.
Meget sjælden:
Rare: manic reactions, agitation, anxiety, depersonalisation, panic attacks, akathisia (see section 4.4 Special Warnings and Special Precautions for use).
Gastrointestinal blødning.
These symptoms may also be due to the underlying disease
Forhøjede leverenzymer.
Nervous system disorders Common: dizziness, tremor Uncommon: extrapyramidal disorders Rare: convulsions.
Leverpåvirkning (f. eks. hepatitis, undertiden forbundet med gulsot og/ eller leversvigt).
Very rare: serotonin syndrome (symptoms may include agitation, confusion, diaphoresis, hallucinations, hyperreflexia, myoclonus, shivering, tachycardia and tremor).
Der er også meget sjældent modtaget post- marketing rapporter om leverpåvirkning (hepatitis, undertiden forbundet med gulsot og/ eller leversvigt).
Reports of extrapyramidal disorder including oro-facial dystonia have been received in patients sometimes with underlying movement disorders or who were using neuroleptic medication.
Dermatologiske lidelser Almindelig:
Eye disorders Common: blurred vision.
Usædvanlig:
Very rare: acute glaucoma.
Meget sjælden:
Cardiac disorders Uncommon: sinus tachycardia.
Fotosensibilitet.
Rare: bradycardia.
Urinretention.
Vascular disorders Uncommon: transient increases or decreases in blood pressure.
Forstyrrelser i reproduktion og lidelser i mammae Meget almindelig:
Respiratory, thoracic and mediastinal disorders Common: yawning.
Sjælden:
Gastrointestinal disorders Very common: nausea.
Hyperprolaktinæmi/ galaktorré.
Common: constipation, diarrhoea, dry mouth.
Priapisme.
Very rare: gastrointestinal bleeding.
Artalgi, myalgi
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Generelle symptomer og forstyrrelser ved applikationssted Almindelig:
Post-marketing reports of hepatic events (such as hepatitis, sometimes associated with jaundice and/ or liver failure) have also been received very rarely.
Asteni, vægtforøgelse.
Skin and subcutaneous tissue disorders Common: sweating.
Meget sjælden:
Uncommon: skin rashes, pruritus Very rare: photosensitivity reactions.
Perifert ødem.
Renal and urinary disorders Uncommon: urinary retention.
SYMPTOMER VED SEPONERING AF PAROXETIN Almindelig:
Reproductive system and breast disorders Very common: sexual dysfunction.
Svimmelhed, sensoriske forstyrrelser, søvnforstyrrelser, angst, hovedpine.
Rare: hyperprolactinaemia/ galactorrhoea.
Usædvanlig:
Very rare: priapism.
Agitation, kvalme, tremor, konfusion, svedtendens, emotionel uligevægt, synsforstyrrelser, hjertebanken, diarré, irritabilitet.
Uncommon: agitation, nausea, tremor, confusion, sweating, emotional instability, visual disturbances, palpitations, diarrhoea, irritability.
Hos de fleste patienter er disse symptomer milde til moderate og forbigående, men hos nogle patienter kan de være svære og/ eller langvarige.
Generally these events are mild to moderate and are self-limiting, however, in some patients they may be severe and/ or prolonged.
Det anbefales derfor, når paroxetinbehandling ikke længere er påkrævet, at seponere medicinen gradvist ved nedtrapning af dosis (se 4. 2 Dosering og indgivelsesmåde og 4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen).
It is therefore advised that when paroxetine treatment is no longer required, gradual discontinuation by dose tapering should be carried out (see section 4.2 Posology and Method of Administration and section 4.4 Special Warnings and Special Precautions for use).
Øget selvmordsrelateret adfærd (herunder selvmordsforsøg og selvmordstanker), selvdestruktive handlinger og øget fjendtlighed.
ADVERSE EVENTS FROM PAEDIATRIC CLINICAL TRIALS In short-term (up to 10-12 weeks) clinical trials in children and adolescents, the following adverse events were observed in paroxetine treated patients at a frequency of at least 2% of patients and occurred at a rate at least twice that of placebo were: increased suicidal related behaviours (including suicide attempts and suicidal thoughts), self-harm behaviours and increased hostility.
Patienterne restitueredes generelt uden alvorlige følgetilstande, også i tilfælde hvor doser på op til 2000 mg er blevet taget på en gang.
In studies that used a tapering regimen, symptoms reported during the taper phase or upon discontinuation of paroxetine at a frequency of at least 2% of patients and occurred at a rate at least twice that of placebo were: emotional lability (including crying, mood fluctuations, self-harm, suicidal thoughts and attempted suicide), nervousness, dizziness, nausea and abdominal pain (see section 4.4 Special Warnings and Special Precautions for use).
FARMAKOLOGISKE EGENSKABER
CHMP/ 187488/ 2004 4.9 Overdose
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5. 1 Farmakodynamiske egenskaber
Symptoms and Signs
Farmakoterapeutisk klassifikation:
A wide margin of safety is evident from available
N06A B05.
overdose information on paroxetine.
Virkningsmekanisme Paroxetin er en potent og selektiv hæmmer af optagelsen af 5- hydroxitryptamin (5- HT, serotonin), og dets antidepressive virkning og effektivitet ved behandling af OCD, socialangst/ socialfobi, generaliseret angst, posttraumatisk stress syndrom og panikangst anses for at være forbundet med dets specifikke hæmning af optagelsen af 5- HT i hjerneneuroner.
Experience of paroxetine in overdose has indicated that, in addition to those symptoms mentioned under section 4.8 "Undesirable Effects", vomiting, dilated pupils, fever, blood pressure changes, headache, involuntary muscle contractions, agitation, anxiety and tachycardia have been reported.
Paroxetin er kemisk ikke relateret til tricykliske, tetracykliske og andre tilgængelige antidepressiva.
Patients have generally recovered without serious sequelae even when doses of up to 2000 mg have been taken alone.
Denne mangel på interaktion med postsynaptiske receptorer in vitro underbygges af in vivo undersøgelser, som har vist mangel på CNS- nedsættende og hypotensive egenskaber.
Events such as coma or ECG changes have occasionally been reported and, very rarely with a fatal outcome, but generally when paroxetine was taken in conjunction with other psychotropic drugs, with or without alcohol.
Farmakodynamiske virkninger Paroxetin nedsætter ikke den psykomotoriske funktion og forstærker heller ikke ethanols depressive virkninger.
The treatment should consist of those general measures employed in the management of overdose with any antidepressant.
Ligesom andre selektive 5- HT- optagshæmmere giver paroxetin symptomer på øget 5- HT - receptorstimulation ved indgift hos dyr, som tidligere har fået MAO- hæmmere eller tryptofan.
Where appropriate, the stomach should be emptied either by the induction of emesis, lavage or both.
Adfærds - og EEG- undersøgelser viser, at paroxetin virker svagt aktiverende ved doser, der generelt ligger over det, der kræves for at hæmme 5- HT- optagelsen.
Following evacuation, 20 to 30 g of activated charcoal may be administered every 4 to 6 h during the first 24 h after ingestion.
Aktiveringsegenskaberne er ikke af "amfetaminlignende" art.
Supportive care with frequent monitoring of vital signs and careful observation is indicated.
Dyreforsøg viser, at paroxetin tolereres godt af hele hjerte- kar- systemet.
PHARMACOLOGICAL PROPERTIES
Paroxetin producerer ingen klinisk signifikante ændringer i blodtryk, hjertefrekvens og ECG efter indgift hos raske individer.
N06A B05
Undersøgelser viser, at paroxetin i modsætning til antidepressiva, som hæmmer optagelsen af noradrenalin, har langt mindre tilbøjelighed til at hæmme de antihypertensive virkninger af guanethidin.
Mechanism of Action Paroxetine is a potent and selective inhibitor of 5-hydroxytryptamine (5-HT, serotonin) uptake and its antidepressant action and effectiveness in the treatment of OCD, Social Anxiety disorder/ Social Phobia, General Anxiety Disorder, Post-traumatic Stress Disorder and Panic Disorder is thought to be related to its specific inhibition of 5-HT uptake in brain neurones.
Ved behandling af depressionssygdomme kan paroxetins virkning sammenlignes med standardantidepressiva.
Paroxetine is chemically unrelated to the tricyclic, tetracyclic and other available antidepressants.
Der er også visse tegn på, at paroxetin kan være af terapeutisk værdi for patienter, som ikke reagerer på standardbehandling.
Paroxetine has low affinity for muscarinic cholinergic receptors and animal studies have indicated only weak anticholinergic properties.
Morgendosering med paroxetin har ingen skadelig virkning på søvnens kvalitet eller varighed.
In accordance with this selective action, in vitro studies have indicated that, in contrast to tricyclic antidepressants, paroxetine has little affinity for alpha1, alpha2 and beta-adrenoceptors, dopamine (D2), 5-HT1 like, 5-HT2 and histamine (H1) receptors.
Patienterne vil desuden sandsynligvis opleve, at de sover bedre, når de begynder at reagere på paroxetinbehandlingen.
This lack of interaction with post-synaptic receptors in vitro is substantiated by in vivo studies which demonstrate lack of CNS depressant and hypotensive properties.
Dosis respons I studier med fast dosis er dosis respons kurven flad, og tyder således ikke på en fordel med hensyn til effekt, for at bruge større doser end anbefalet.
Pharmacodynamic Effects Paroxetine does not impair psychomotor function and does not potentiate the depressant effects of ethanol.
Der er dog nogle kliniske data, som tyder på at optitrering af dosis kan være fordelagtigt for nogle patienter.
As with other selective 5-HT uptake inhibitors, paroxetine causes symptoms of excessive 5-HT receptor stimulation when administered to animals previously given monoamine oxidase (MAO) inhibitors or tryptophan.
Langtidsvirkning Paroxetins langtidsvirkning på depression er påvist i en vedligeholdelsesundersøgelse af 52 ugers varighed med recidivforebyggelse:
Behavioural and EEG studies indicate that paroxetine is weakly activating at doses generally above those required to inhibit 5-HT uptake.
12% af de patienter, der fik paroxetin (20- 40 mg dagligt), recidiverede sammenlignet med 28% af de patienter, der fik placebo.
The activating properties are not "amphetamine-like" in nature.
Paroxetins langtidsvirkning ved behandling af OCD er undersøgt i tre vedligeholdelsesundersøgelser af 24 ugers varighed med recidivforebyggelse.
Animal studies indicate that paroxetine is well tolerated by the cardiovascular system.
I en af de tre undersøgelser blev der påvist en væsentlig forskel i forholdet mellem paroxetinrecidivister (38%) og placeborecidivister (59%).
Paroxetine produces no clinically significant changes in blood pressure, heart rate and ECG after administration to healthy subjects.
5% af de patienter, der fik paroxetin (10- 40 mg
Studies indicate that, in contrast to antidepressants which inhibit the uptake of noradrenaline, paroxetine has a much reduced propensity to inhibit the antihypertensive effects of guanethidine.
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dagligt), recidiverede sammenlignet med 30% af de patienter, der fik placebo.
5% of patients receiving paroxetine (10-40mg daily) relapsed, versus 30% of patients on placebo.
Dette blev underbygget af en vedligeholdelsesundersøgelse af 36 ugers varighed.
This was supported by a 36 week maintenance study.
5. 2 Farmakokinetiske egenskaber
5.2 Pharmacokinetics
Absorption Paroxetin absorberes godt efter oral dosering og undergår first- pass- metabolisme.
Absorption Paroxetine is well absorbed after oral dosing and undergoes first-pass metabolism.
På grund af first - pass- metabolisme er paroxetinmængden til systemisk cirkulation mindre end den mængde, der absorberes fra mave- tarm- kanalen.
Due to first-pass metabolism, the amount of paroxetine available to the systemic circulation is less than that absorbed from the gastrointestinal tract.
Der forekommer delvis mætning af first- pass- virkningen og reduceret plasmaclearance, når kropsbelastningen stiger med højere enkeltdoser eller flere doser.
Partial saturation of the first-pass effect and reduced plasma clearance occur as the body burden increases with higher single doses or on multiple dosing.
Dette giver uforholdsmæssige stigninger i plasmakoncentrationerne af paroxetin, og de farmakokinetiske parametre er således ikke konstante, hvilket giver ikke- lineær kinetik.
This results in disproportionate increases in plasma concentrations of paroxetine and hence pharmacokinetic parameters are not constant, resulting in non-linear kinetics.
Steady state indtræder 7- 14 dage efter behandlingens start med standard eller controlled release formuleringer, og de farmakokinetiske egenskaber lader ikke til at ændre sig under langtidsbehandling.
Steady state systemic levels are attained by 7 to 14 days after starting treatment with immediate or controlled release formulations and pharmacokinetics do not appear to change during long-term therapy.
Paroxetins proteinbindingsgrad i terapeutiske koncentrationer er ca.
Distribution Paroxetine is extensively distributed into tissues and pharmacokinetic calculations indicate that only 1% of the paroxetine in the body resides in the plasma.
95%.
Approximately 95% of the paroxetine present is protein bound at therapeutic concentrations.
Metabolismen kompromitterer ikke paroxetins selektive virkning på optagelsen af neuronal 5- HT.
Transfer to human breast milk, and to the foetuses of laboratory animals, occurs in small amounts.
Udskillelsen af metabolitter sker i to faser – først som følge af first- pass- metabolisme og derefter ved systemisk eliminering af paroxetin.
Metabolism The principal metabolites of paroxetine are polar and conjugated products of oxidation and methylation which are readily cleared.
I toksikologiske undersøgelser af rhesusaber og albinorotter svarer den metaboliske pathway til den, der er beskrevet for mennesker.
In view of their relative lack of pharmacological activity, it is most unlikely that they contribute to paroxetine's therapeutic effects.
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Reproduktionstoksicitetsundersøgelser af rotter har vist, at paroxetin påvirker den mandlige og kvindelige fertilitet.
Toxicology studies have been conducted in rhesus monkeys and albino rats; in both, the metabolic pathway is similar to that described for humans.
Der er observeret øget dødelighed og forsinket knogledannelse hos unger.
Genotoxicity was not observed in a battery of in vitro and in vivo tests.
Sidstnævnte virkninger var sandsynligvis forbundet med svangerskabsforgiftning og anses ikke for at påvirke fostre/ nyfødte unger direkte.
In rats, increased pup mortality and delayed ossification were observed.
6. 6 Instruktioner vedrørende håndtering
MARKETING AUTHORISATION HOLDER
[Udfyldes nationalt]
CHMP/ 187488/ 2004 [To be completed nationally]
7.
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 EMEA 2005
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• Medlemsstaterne bør sikre, at relevante lægemiddelformer/ styrker kan blive gjort tilgængelige med henblik på at muliggøre op - og nedtitrering i overensstemmelse med de anbefalinger vedrørende dosering, der angives i produktresumeet, som er vedlagt bilag III til denne udtalelse.
• Member States should ensure that appropriate pharmaceutical forms / strengths can be made available in order to facilitate up and down titration in accordance to the posology recommendations stated in the SPC attached to Annex III of this Opinion.
• Periodiske sikkerhedsindberetninger skal hver 6. måned tilsendes referencemedlemsstaterne og/ eller de nationale kompetente myndigheder i de næste 2 år.
• 6-monthly Periodic Safety Update Reports should be provided to the Reference Member States and/ or National Competent Authorities for the next 2 years.
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London, 27 april 2004 EMEA/ CPMP/ 3122/ 04
London, 27 April 2004 EMEA/ CPMP/ 3122/ 04
Pidolma
Pidolma
Ansøgeren indgav en ansøgning om gensidig anerkendelse af amlodipinmaleat på grundlag af den markedsføringstilladelse, Sverige udstedte den 21. februar 2003.
The applicant submitted an application for mutual recognition of amlodipine maleate on the basis of the marketing authorisation granted by Sweden on 21 February 2003.
Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa- Kommissionen den 27 april 2004.
The final opinion was converted into a Decision by the European Commission on 27 April 2004.
EMEA/ CPMP/ 3122/ 04
EMEA/ CPMP/ 3122/ 04
markedsføringstilladelsen
administration
Laboratoires Delbert 56, Quai A.
Laboratoires Delbert 56, Quai A.
Le Gallo 92100 Boulogne Billancourt Frankrig
Le Gallo 92100 Boulogne Billancourt France
EMEA/ CPMP/ 3122/ 04 FAGLIGE KONKLUSIONER
EMEA/ CPMP/ 3122/ 04 SCIENTIFIC CONCLUSIONS
LÆGEMIDLETS NAVN
EMEA/ CPMP/ 3122/ 04 1 NAME OF THE MEDICINAL PRODUCT
Pidolma 5 mg tabletter Pidolma 10 mg tabletter
Pidolma 5 mg tablets Pidolma 10 mg tablets
Pidolma 5 mg tabletter:
Pidolma 5 mg tablet:
Pidolma 10 mg tabletter:
Pidolma 10 mg tablet:
Pidolma 5 mg tabletter er hvide, runde og bikonvekse, diameter ca.
Pidolma 5 mg tablets are white, round and biconvex, diameter approx.
Pidolma 10 mg tabletter er hvide, runde og bikonvekse, med delekærv på begge sider, diameter ca.
Pidolma 10 mg tablets are white, round and biconvex, scored on both sides, diameter approx.
Pædiatriske patienter Pidolma bør ikke gives til børn da sufficient klinisk erfaring mangler.
Paediatric patients Pidolma tablets should not be given to children due to insufficient clinical experience.
4. 3 Kontraindikationer EMEA/ CPMP/ 3122/ 04 Pidolma tabletter er kontraindikeret ved:
EMEA/ CPMP/ 3122/ 04 4.3 Contraindications
• patienter med kendt overfølsomhed over for amlodipin, andre dihydropyridiner eller over for et eller flere af hjælpestofferne. • svær hypotension. • shock. • hjerteinsufficiens efter akut myokardieinfarkt (under de første 28 dage). • obstruktion af venstre ventrikels udløbskanal (f. eks. omfattende aortastenose). • Instabil angina pectoris.
patients with known hypersensitivity to amlodipine, other dihydropyridines or any of the excipients severe hypotension shock heart failure after acute myocardial infarction (during the first 28 days) obstruction of the outflow-tract of the left ventricle (e. g. high grade aortic stenosis) instable angina pectoris
EMEA/ CPMP/ 3122/ 04 4. 8 Bivirkninger
EMEA/ CPMP/ 3122/ 04
Almindelige:
In patients suffering from dizziness, headache, fatigue or nausea the ability to react may be impaired.
Usædvanlige Sjældne Meget sjældne
Very rare:
EMEA/ CPMP/ 3122/ 04
EMEA/ CPMP/ 3122/ 04 Hepato-biliary system Uncommon:
Almindelige:
Ankle swelling
Den aktive virkestof i Pidolma tabletter, amlodipin et dihydropyridin derivat, er et chiralt stof, sammensat af et racemat.
The active substance in Pidolma tablets, the dihydropyridine derivative amlodipine, is a chiral substance, composed of a racemate.
Pidolma tabletter kan anvendes i kombination med betablokkere, saluretika, ACE- hæmmere eller som monoterapi.
Pidolma tablets can be used in combination with beta-blockers, saluretics, ACE inhibitors, or as monotherapy.
Pidolma tabletter kan anvendes i kombination med betablokkere, nitrater eller som monoterapi ved angina pectoris.
Pidolma tablets can be used in combination with beta-blockers, nitrates or as monotherapy in angina pectoris.
EMEA/ CPMP/ 3122/ 04
EMEA/ CPMP/ 3122/ 04 Patients with hepatic impairment:
6. 2 Uforligeligheder
6.2 Sodium stearyl fumarate. Incompatibilities
Tabletter 5 mg: blisterpakning af aluminium/ aluminium 10, 20, 28, 30, 50, 56, 98, 100, 300 tabletter, 50 x 1 tabletter (enkelt dosis), 100 x 1 tabletter (enkelt dosis).
Blister packs, aluminium/ aluminium 10, 20, 28, 30, 50, 56, 98, 100, 300 tablets, 50 x 1 tablets (unit dose), 100 x 1 tablets (unit dose).