scheduling status proprietary name and dosage … · strength(s): each capsule contains 2 mg...

Product Proprietary Name: IMODIUM® CAPS

Dosage Form: Capsules

Strength(s): Each capsule contains 2 mg loperamide hydrochloride

Amendment: Response to CCC July 2014 (RA/2014/10/026 HR)

Date Submitted : 30 October 2014

of 27 CCDS Dec 2010

SCHEDULING STATUS

Schedule 2

PROPRIETARY NAME AND DOSAGE FORM

IMODIUM® CAPS capsules

COMPOSITION

Each capsule contains 2 mg loperamide hydrochloride.

The other ingredients are:

Lactose monohydrate, maize starch, talc and magnesium stearate. The capsule

itself is made from yellow ferric oxide, indigotindisulphonate sodium, black ferrous

oxide, erythrosine sodium, titanium dioxide and gelatin.

PHARMACOLOGICAL CLASSIFICATION

A.11.9 Medicines acting on gastro-intestinal tract. Anti-diarrhoeals

PHARMACOLOGICAL ACTION

Pharmacodynamic Properties

Loperamide hydrochloride inhibits hypermotility by direct action on the bowel wall.

Its inhibition of peristalsis is the result of decreasing the activity of both the

longitudinal muscles (preparatory and reflex phases) and the circular muscles






of 27 CCDS Dec 2010

(reflex phase). Loperamide hydrochloride normalises the stool in both acute and

chronic diarrhoea.

Pharmacokinetic Properties

Loperamide hydrochloride is incompletely absorbed from the gut, and it is almost

completely metabolised in the liver where it is conjugated and excreted via the bile.

Loperamide hydrochloride is mainly eliminated via the faeces.

INDICATIONS

Adults and children 6 years and older

for the control and symptomatic relief of acute and chronic non-specific

diarrhoea

inhibition of peristalsis and slowing intestinal transit time in patients with

ileostomies, colostomies and other intestinal resections.

CONTRA-INDICATIONS

patients with a known hypersensitivity to loperamide hydrochloride or to

any of the excipients.

infants below 24 months of age.

IMODIUM CAPS should not be used as the primary therapy:

o in patients with acute dysentery, which is characterised by

blood in stools and high fever,

o patients with acute ulcerative colitis,






of 27 CCDS Dec 2010

o patients with bacterial enterocolitis caused by invasive

organisms including Salmonella, Shigella, and

Campylobacter,

o patients with pseudomembranous colitis associated with the

use of broad-spectrum antibiotics.

o Ileus irrespective of cause

WARNINGS AND SPECIAL PRECAUTIONS

IMODIUM CAPS should not be used when inhibition of peristalsis is to be avoided

due to the possible risk of significant sequelae including ileus, megacolon and

toxic megacolon. IMODIUM CAPS must be discontinued promptly when

constipation, abdominal distension or ileus develop.

Lactose intolerance and lactase deficiency

IMODIUM CAPS contain lactose. Patients with rare hereditary problems of

galactose intolerance, the Lapp lactase deficiency or glucose-galactose

malabsorption should not take this medicine.

Special Precautions:

Treatment of diarrhoea with IMODIUM CAPS is only symptomatic. Whenever an

underlying aetiology can be determined, specific treatment should be given when

appropriate (or when indicated).






of 27 CCDS Dec 2010

In patients with diarrhoea, especially in children, fluid and electrolyte depletion

may occur. In such cases administration of appropriate fluid and electrolyte

replacement (oral rehydration therapy [ORT]) is the most important measure.

IMODIUM CAPS should not be given to children less than 6 years of age.

IMODIUM CAPS is not recommended for use in acute or chronic diarrhoea in

children under the age of 6 years.

HIV infected patients treated with IMODIUM CAPS

for diarrhoea should have therapy stopped at the earliest signs of

abdominal distension. There have been reports of toxic megacolon in HIV

infected patients with infectious colitis from both viral and bacterial

pathogens treated with IMODIUM CAPS.

Although no pharmacokinetic data are available in patients with hepatic

impairment, IMODIUM CAPS should be used with caution in such patients

because of reduced first pass metabolism. Patients with hepatic dysfunction

should be monitored closely for signs of central nervous system toxicity.

Effects on ability to drive and use machines:

Since IMODIUM CAPS can cause dizziness, patients must take special

precaution when using IMODIUM CAPS before driving or operating machinery.






of 27 CCDS Dec 2010

INTERACTIONS

Non-clinical data have shown that loperamide is a P-glycoprotein substrate.

Concomitant administration of loperamide (16 mg single dose) with quinidine, or

ritonavir, which are both P-glycoprotein inhibitors, resulted in a 2 to 3-fold increase

in loperamide plasma levels. The clinical relevance of this pharmacokinetic

interaction with P-glycoprotein inhibitors, when loperamide is given at

recommended dosages, is unknown.

The concomitant administration of IMODIUM CAPS (4 mg single dose) and

itraconazole, an inhibitor of CYP3A4 and P-glycoprotein, resulted in a 3 to 4-fold

increase in loperamide plasma concentrations. In the same study a CYP2C8

inhibitor, gemfibrozil, increased loperamide by approximately 2-fold. The

combination of itraconazole and gemfibrozil resulted in a 4-fold increase in peak

plasma levels of loperamide and a 13-fold increase in total plasma exposure.

The concomitant administration of IMODIUM CAPS (16 mg single dose) and

ketoconazole, an inhibitor of CYP3A4 and P-glycoprotein, resulted in a 5-fold

increase in loperamide plasma concentrations.

Concomitant treatment with oral desmopressin resulted in a 3-fold increase of

desmopressin plasma concentrations, presumable due to slower gastrointestinal

motility.






of 27 CCDS Dec 2010

It is expected that medicines with similar pharmacological properties may

potentiate loperamide’s effect and that medicines that accelerate gastrointestinal

transit may decrease its effects.

PREGNANCY AND LACTATION

The safety of use during pregnancy and lactation has not been established.

IMODIUM CAPS should not be used during pregnancy.

Small amounts of loperamide may appear in human breast milk. Therefore,

IMODIUM CAPS should not be used by mothers breastfeeding their infant.

DOSAGE AND DIRECTIONS FOR USE

IMODIUM CAPS are not suited for children under 6 years of age.

IMODIUM CAPS should be taken with liquid.

Acute non specific diarrhoea

For adults and children of 6 years and older: 2 capsules (4 mg) for adults or 1

capsule (2 mg) for children as an initial dose, followed by 1 capsule (2 mg) after

each subsequent loose stool.






of 27 CCDS Dec 2010

Do not exceed the following maximum daily dosages:

WEIGHT IN KILOGRAMS (kg) MAXIMUM DAILY DOSE

from 27 kg 4 capsules (8 mg)





IMODIUM CAPS should be stopped as soon as diarrhoea is under control.

In acute diarrhoea, if clinical improvement is not observed within 48 hours, the

administration of IMODIUM CAPS should be discontinued and patients should be

advised to consult their doctor.

Chronic non specific diarrhoea

The initial dose is 2 capsules (4 mg) daily for adults and 1 capsule (2 mg) daily for

children of 6 years and over.

The initial dose should be adjusted until 1 - 2 solid stools per day are obtained.

This is usually achieved on a maintenance dose of 1 - 6 capsules (2 mg – 12 mg)

daily. If constipation occurs, the dosage should be decreased.

The maximum dose for acute and chronic diarrhoea is 8 capsules (16 mg) daily

for adults; in children it must be related to body weight (3 capsules/20 kg).






of 27 CCDS Dec 2010

Elderly

No dose adjustment is required for the elderly.

Renal impairment

No dose adjustment is required for patients with renal impairment.

Hepatic impairment

Although no pharmacokinetic data are available in patients with hepatic

impairment, IMODIUM CAPS should be used with caution in such patients

because of reduced first pass metabolism. (see WARNINGS AND SPECIAL

PRECAUTIONS).

SIDE-EFFECTS

Throughout this section, adverse reactions are presented. Adverse

reactions are adverse events that were considered to be reasonable

associated with the use of IMODIUM CAPS based on the comprehensive

assessment of the available adverse event information. A causal

relationship with IMODIUM CAPS cannot be reliably established in individual

cases. Further, because clinical trials are conducted under widely varying

conditions, adverse reaction rates observed in the clinical trials of a






of 27 CCDS Dec 2010

medicine cannot be directly compared to rates in the clinical trials of

another medicine and may not reflect the rates observed in clinical practice.

Adults and children aged ≥ 12 years

The safety of loperamide HCl was evaluated in 2 755 adults and children aged

≥ 12 years who participated in 26 controlled and uncontrolled clinical trials of

loperamide HCl used for the treatment of acute diarrhoea.

The most commonly reported (i.e. ≥ 1% incidence) adverse drug reactions (ADRs)

in clinical trials with loperamide HCl in acute diarrhoea were: constipation (2,7%),

flatulence (1,7%), headache (1,2%) and nausea (1,1%).

Table 1 displays ADRs that have been reported with the use of loperamide HCl

from either clinical trial (acute diarrhoea) or post-marketing experience.

The frequency categories use the following convention: very common (≥ 1/10);

common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000

to < 1/1 000); and very rare (< 1/10 000).

Table 1: Adverse Drug Reactions

System Organ Class Indication

Common Uncommon Rare

Nervous System Disorders Headache Dizziness

Gastrointestinal Disorders Constipation Nausea Flatulence

Abdominal pain Abdominal discomfort Dry mouth Abdominal pain upper Vomiting

Abdominal distension






of 27 CCDS Dec 2010

Skin and Subcutaneous Tissue Disorders

Rash

The table above does not differentiate between chronic and acute indications or adults and children, the frequency is estimated from all clinical trials with loperamide HCl (acute and chronic), including trials in children ≤ 12 years (N=3 683).

Table 2: Adverse drug reactions identified during post-marketing

experience with loperamide HCl in adults and children

Immune system disorders

Hypersensitivity reaction, anaphylactic reaction (including anaphylactic shock) and

anaphylactoid reaction

Nervous system disorders

Coordination abnormality, depressed level of consciousness, hypertonia, loss of consciousness,

somnolence, stupor

Eye disorders

Miosis

Gastrointestinal disorders

Ileus (including paralytic ileus), megacolon (including toxic megacolon)

Skin and subcutaneous tissue disorders

Angioedema, bullous eruption (including Stevens-Johnson syndrome,

toxic epidermal necrolysis and erythema multiforme), pruritis, urticaria






of 27 CCDS Dec 2010

Renal and urinary disorders

Urinary retention

General disorders and administration site conditions

Fatigue

See section WARNINGS AND SPECIAL PRECAUTIONS

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS

TREATMENT

In case of overdose (including relative overdose due to hepatic

dysfunction), central nervous system depression (e.g. stupor, coordination

abnormality, somnolence, miosis, muscular hypertonia and respiratory

depression), urinary retention, constipation and paralytic ileus may occur.

Children may be more sensitive to central nervous system effects of loperamide

than adults. Convulsions have been reported in children under the age of 2 years.

Excessive inhibition of peristalsis with nausea and dryness of the mouth.

Treatment is symptomatic and supportive. Naloxone can be given as an antidote.

Since the duration of action of IMODIUM CAPS is longer than that of naloxone (1

to 3 hours) repeated treatment with naloxone might be indicated. Therefore, the

patient should be monitored closely for at least 48 hours in order to detect

possible central nervous system depression.






of 27 CCDS Dec 2010

IDENTIFICATION

White powder filled into hard capsules with opaque green cap and opaque dark

grey body.

PRESENTATION

Cartons containing one or more blister packs of 6 capsules each.

STORAGE DIRECTIONS

Store at or below 25 ºC. Protect from light.

KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER

U/11.9/213

Namibia Reg. No.:90/11.9/00623

NS1

Zimbabwe Reg. No.:82/16.6/1575

P

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE

OF REGISTRATION






of 27 CCDS Dec 2010

JANSSEN PHARMACEUTICA (Pty) Ltd

(Reg no. 1980/011122/07)

Building 6, Country Club Estate,

21 Woodlands Drive, Woodmead, 2191

Tel: +27 (11) 518 7000

www.janssen.co.za

DATE OF PUBLICATION OF THIS PACKAGE INSERT

12 June 2015

http://www.janssen.co.za/






of 27 CCDS Dec 2010

SKEDULERINGSTATUS

Skedule 2

HANDELSNAAM EN DOSEERVORM

IMODIUM® CAPS kapsules

SAMESTELLING

Elke kapsule bevat 2 mg loperamiedhidrochloried

Die ander bestanddele is:

Laktosemonohidraat, mieliestysel, talk en magnesiumstearaat.

Die kapsule self bestaan uit geel ysteroksied,

natriumindigotiendisulfonaat, swart ysteroksied, natriumeritrosien,

titaandioksied en gelatien.

FARMAKOLOGIESE KLASSIFIKASIE

A 11.4.3 Middels met uitwerking op maagdermkanaal. Diarreemiddels

FARMAKOLOGIESE WERKING

Farmakodinamiese eienskappe

Loperamiedhidrochloried inhibeer hipermotiliteit deur direkte werking op die

dikdermwand. Die inhibering van peristalse is die gevolg van ’n afname in die

werksaamheid van beide die langspiere (voorbereidende- en refleksfases) en die






of 27 CCDS Dec 2010

kringspiere (refleksfase). Loperamiedhidrochloried normaliseer die stoelgang by

akute en ook chroniese diarree.

Farmakokinetiese eienskappe

Loperamiedhidrochloried word onvolledig uit die dermkanaal geabsorbeer, en dit

word amper volledig in die lewer gemetaboliseer, waar dit gekonjugeer word en

deur die gal uitgeskei word. Loperamiedhidrochloried word hoofsaaklik deur die

feses uitgeskei.

INDIKASIES

Volwassenes en kinders 6 jaar en ouer

vir die beheer en simptomatiese verligting van akute en chroniese nie-

spesifieke diarree

inhibering van peristalse en vertraging van inwendige deurgangstyd by

pasiënte met ileostomieë, kolostomieë en ander inwendig reseksies.

KONTRA-INDIKASIES

pasiënte met 'n bekende hipersensitiwiteit vir loperamiedhidrochloried of

vir enige van die mengmiddels.

kleuters onder 24 maande oud.

IMODIUM CAPS moet nie as primêre behandeling gebruik word nie:

o by pasiënte met akute disenterie, wat gekenmerk word deur

bloed in die stoelgang en hoë koors,






of 27 CCDS Dec 2010

o pasiënte met akute ulseratiewe kolitis,

o pasiënte met bakteriële enterokolitis veroorsaak deur

indringende organismes, insluitende Salmonella, Shigella en

Campylobacter,

o pasiënte met pseudomembraneuse kolitis geassosieer met

die gebruik van breëspektrum antibiotika,

o dermobstruksie, ongeag die oorsaak

WAARSKUWINGS EN SPESIALE VOORSORGMAATREËLS

IMODIUM CAPS moet nie gebruik word wanneer die inhibisie van peristalse

vermy moet word nie, as gevolg van die moontlike risiko van beduidende gevolge

waaronder dermobstruksie, megakolon en toksiese megakolon. IMODIUM CAPS

moet dadelik gestaak word wanneer hardlywigheid, opgehewe buik of

dermobstruksie ontwikkel.

Laktose-intoleransie en laktase-tekort

IMODIUM CAPS bevat laktose. Pasiënte met seldsame oorerflike probleme van

galaktose intoleransie, die Laplander-laktasetekort of glukose-galaktose

wanabsorpsie moet nie hierdie medisyne neem nie.






of 27 CCDS Dec 2010

Spesiale Voorsorgmaatreëls:

Behandeling van diarree met IMODIUM CAPS is slegs simptomaties. Wanneer ’n

onderliggende oorsaak van die siekte bepaal kan word, moet spesifieke

behandeling gegee word wanneer toepaslik (of wanneer aangedui).

By pasiënte met diarree, veral by kinders, kan vloeistof- en elektrolietuitputting

voorkom. In sulke gevalle is die toediening van toepaslike vloeistof- en

elektrolietaanvulling (orale rehidrasieterapie [ORT]) die mees belangrike maatreël.

IMODIUM CAPS moet nie aan kinders jonger as 6 jaar oud gegee word nie.

IMODIUM CAPS word nie aanbeveel vir gebruik by akute of chroniese diarree by

kinders onder 6 jaar oud nie.

MIV-geïnfekteerde pasiënte wat met IMODIUM CAPS vir diarree behandel

word se behandeling moet by die eerste tekens van opgehewenheid van die

buik gestaak word. Daar is berigte ontvang van toksiese megakolon by MIV-

geïnfekteerde pasiënte met infektiewe kolitis te wyte aan virale of bakteriële

patogene, wat met IMODIUM CAPS behandel is.

Alhoewel geen farmakokinetiese data beskikbaar is oor pasiënte met

lewerinkorting nie, moet IMODIUM CAPS met omsigtigheid by sulke pasiënte

gebruik word as gevolg van die verminderde eerstedeurgangmetabolisme.






of 27 CCDS Dec 2010

Pasiënte met lewerdisfunksie moet noukeurig gemoniteer word vir tekens van

sentrale senuweestelsel toksisiteit.

Effek op die vermoë om te bestuur en masjinerie te gebruik:

Aangesien IMODIUM CAPS duiseligheid kan veroorsaak, moet pasiënte veral

versigtig wees as hulle IMODIUM CAPS neem voordat hulle bestuur of masjinerie

hanteer.

INTERAKSIES

Nie-kliniese data het getoon dat loperamied ’n P-glikoproteïen substraat is.

Gelyktydige toediening van loperamied ('n 16 mg- enkeldosis) met kinidien of

ritonavir, wat beide P-glikoproteïenremmers is, het gelei tot 'n 2 to 3-voudige

toename in die plasmavlakke van loperamied. Die kliniese relevansie van hierdie

farmakokinetiese interaksie met

P-glikoproteïen inhibeerders, wanneer loperamied by aanbevole doserings

geneem word, is onbekend.

Die gesamentlike toediening van IMODIUM CAPS (4 mg- enkele dosis) en

itrakonasool, 'n CYP3A4- en P-glikoproteïenremmer, het gelei tot ’n 3- tot 4-

voudige toename in die plasmakonsentrasies van loperamied. In dieselfde studie

het 'n CYP2C8- remmer, gemfibrosiel, loperamied ongeveer 2-voudig verhoog.

Die kombinasie van itrakonasool en gemfibrosiel het gelei tot 'n 4-voudige






of 27 CCDS Dec 2010

toename in die piek plasmavlakke van loperamied en 'n 13-voudige toename in

totale plasmablootstelling.

Die gesamentlike toediening van IMODIUM CAPS (’n 16 mg- enkeldosis) en

ketokonasool, 'n CYP3A4- en P-glikoproteïenremmer, het gelei tot ’n 5-voudige

toename in die plasmakonsentrasies van loperamied.

Gelyktydige behandeling met mondelike desmopressien het gelei tot 'n 3-voudige

toename in desmopressien plasmakonsentrasies, vermoedelik weens stadiger

gastro-intestinale beweeglikheid.

Daar word verwag dat medisynes met soortgelyke farmakologiese eienskappe die

effek van loperamied kan potensieer en dat medisynes wat gastro-intestinale

deurgangstyd versnel, die effek daarvan kan verminder.

SWANGERSKAP EN LAKTASIE

Die veiligheid van gebruik tydens swangerskap en borsvoeding is nie bepaal nie.

IMODIUM CAPS moet nie tydens swangerskap gebruik word nie.

Klein hoeveelhede loperamied kan in menslike borsmelk voorkom. Gevolglik

moet IMODIUM CAPS nie deur moeders wat hul babas borsvoed gebruik word

nie.






of 27 CCDS Dec 2010

DOSIS EN GEBRUIKSAANWYSINGS

IMODIUM CAPS is nie geskik vir kinders onder 6 jaar oud nie.

IMODIUM CAPS moet met vloeistof geneem word.

Akute nie-spesifieke diarree

Vir volwassenes en kinders 6 jaar en ouer: 2 kapsules (4 mg) vir volwassenes of 1

kapsule (2 mg) vir kinders as 'n aanvangsdosis, gevolg deur 1 kapsule (2 mg) na

elke daaropvolgende los stoelgang.

Moenie die volgende maksimum daaglikse dosisse oorskry nie:

GEWIG IN KILOGRAM (kg) MAKSIMUM DAAGLIKSE DOSIS

vanaf 27 kg 4 kapsules (8 mg)





IMODIUM CAPS moet gestaak word sodra die diarree onder beheer is.






of 27 CCDS Dec 2010

Indien kliniese verbetering nie binne 48 uur by akute diarree waargeneem word

nie, moet die toediening van IMODIUM CAPS gestaak word en pasiënte moet

aangeraai word om hulle dokter te raadpleeg.

Chroniese nie-spesifieke diarree

Die aanvangsdosis is 2 kapsules (4 mg) daagliks vir volwassenes en 1 kapsule (2

mg) daagliks vir kinders ouer as 6 jaar.

Die aanvangsdosis moet aangepas word totdat 1 - 2 soliede stoelgange per dag

bereik word. Dit word gewoonlik bereik met ’n instandhoudingsdosis van 1 - 6

kapsules (2 mg – 12 mg) daagliks.

Indien hardlywigheid voorkom moet die dosis verminder word.

Die maksimum dosis vir akute en chroniese diarree is 8 kapsules (16 mg) per dag

vir volwassenes; by kinders moet dit verband hou met die liggaamsgewig (3

kapsules/20 kg).

Bejaardes

Dosisaanpassing word nie vir bejaarde persone benodig nie.

Swak nierfunksie

Geen aanpassing in die dosis word benodig by pasiënte met nierontoereikendheid

nie.






of 27 CCDS Dec 2010

Swak lewerfunksie

Alhoewel geen farmakokinetiese data beskikbaar is oor pasiënte met

lewerontoereikendheid nie, moet IMODIUM CAPS met omsigtigheid by sulke

pasiënte gebruik word as gevolg van die verminderde

eerstedeurgangmetabolisme (kyk WAARSKUWINGS EN SPESIALE

VOORSORGMAATREËLS).

NEWE-EFFEKTE

Regdeur hierdie afdeling word ongunstige reaksies voorgelê. Ongunstige

reaksies is ongunstige voorvalle wat geag was om redelik verband te hou

met die gebruik van IMODIUM CAPS, gebaseer op die omvattende

evaluering van die beskikbare inligting oor ongunstige voorvalle. 'n

Oorsaaklike verband met IMODIUM CAPS kan nie betroubaar by individuele

gevalle vasgestel word nie. Daarbenewens, omdat kliniese toetse onder

wyd uiteenlopende omstandighede uitgevoer word, kan die voorkoms van

newe-effekte, soos in die kliniese proewe van 'n medisyne waargeneem

word, nie direk vergelyk word met die voorkoms daarvan in kliniese proewe

van 'n ander medisyne nie en kan dit moontlik nie die voorkoms in die

kliniese praktyk weerspieël nie.






of 27 CCDS Dec 2010

Volwassenes en kinders ≥ 12 jaar

Die veiligheid van loperamiedhidrochloried is geëvalueer by 2 755 volwassenes

en kinders ≥ 12 jaar wat aan 26 gekontroleerde en ongekontroleerde kliniese

proewe van loperamied-HCl, gebruik vir die behandeling van akute diarree,

deelgeneem het.

Die mees algemeen aangemelde (d.w.s. ≥ 1 % voorkoms) ongunstige

geneesmiddelreaksies (OGR's) in kliniese proewe met loperamied-HCl in akute

diarree was: hardlywigheid (2,7 %), winderigheid (1,7 %), hoofpyn (1,2 %) en

naarheid (1,1 %).

Tabel 1 toon die OGRs wat met die gebruik van loperamied-HCl van óf kliniese

proewe (akute diarree) of nabemarkingservaring aangemeld is.

Die frekwensiekategorieë word volgens die volgende gebruik gedefinieer: baie

algemeen (≥ 1/10); algemeen (≥ 1/100 tot <1/10); ongewoon (≥ 1/1 000 tot

< 1/100); seldsaam (≥ 1/10 000 tot < 1/1 000); en baie seldsaam (< 1/10 000).

Tabel 1. Ongunstige geneesmiddelreaksies

Sisteemorgaanklas Indikasie

Algemeen Ongewoon Seldsaam

Senuweestelselversteurings Hoofpyn Duiseligheid

Maagdermkanaal- versteurings

Hardlywigheid Naarheid Winderigheid

Abdominale pyn Buikongemak Droë mond Bobuikpyn Braking

Opgehewe buik






of 27 CCDS Dec 2010

Vel en onderhuidse weefselversteurings

Veluitslag

Die boonste tabel onderskei nie tussen chroniese en akute indikasies of volwassenes en kinders nie, die frekwensie word beraam uit alle kliniese proewe met loperamied-HCl (akuut en chronies), insluitend proewe in kinders ≤ 12 jaar (N=3 683).

Tabel 2: Ongunstige geneesmiddelreaksies wat met ervaring na bemarking

van loperamied-HCl by volwassenes en kinders waargeneem is

Immuunstelselversteurings

Hipersensitiwiteitsreaksies, anafilaktiese reaksie (waaronder anafilaktiese skok)

en anafilaktoïede reaksie

Senuweestelselversteurings

Abnormale koördinasie, onderdrukte vlak van bewussyn, hipertonie, verlies aan bewussyn,

slaperigheid, stupor

Oogversteurings

Miose

Maagdermkanaalversteurings

Dermobstruksie (waaronder paralitiese ileus), megakolon (waaronder toksiese megakolon)

Vel- en onderhuidse weefselversteurings

Angio-edeem, bulleuse uitslag (waaronder Stevens-Johnson-sindroom),

toksiese epidermale nekrolise en veelvormige eriteem), pruritus, urtikarie

Nier- en urienwegversteurings






of 27 CCDS Dec 2010

Urinêre retensie

Algemene versteurings en toestande by die plek van toediening

Moegheid

kyk WAARSKUWINGS EN SPESIALE VOORSORGMAATREËLS

BEKENDE SIMPTOME VAN OORDOSERING EN BESONDERHEDE VAN DIE

BEHANDELING DAARVAN

In geval van oordosering (waaronder relatiewe oordosering te wyte aan

lewerdisfunksie),

sentrale senustelsel-onderdrukking (bv. stupor, abnormale koördinasie,

slaperigheid, miose, hipertoniese spiere en respiratoriese onderdrukking), retensie

van urien, hardlywigheid en paralitiese ileus kan voorkom. Kinders kan meer

gevoelig as volwassenes wees vir die uitwerking van loperamied op die sentrale

senustelsel. Konvulsies is by kinders onder 2 jaar aangemeld.

Oormatige inhibering van peristalse met naarheid en droë mond.

Behandeling is simptomaties en ondersteunend. Naloksoon kan as teenmiddel

gegee word. Aangesien die werkingsduurte van IMODIUM CAPS langer is as dié

van naloksoon (1-3 uur), kan herhaalde behandeling met naloksoon aangedui

wees. Gevolglik moet die pasiënt noukeurig vir ten minste 48 uur gemoniteer

word om moontlike onderdrukking van die sentrale senuweestelsel op te spoor.






of 27 CCDS Dec 2010

IDENTIFIKASIE

'n Wit poeier, gevul in harde kapsules met 'n dofgroen deksel en dowwe

donkergrys romp.

AANBIEDING

Kartonne bevattende een of meer stulpstroke met 6 kapsules elk.

BERGINGSAANWYSINGS

Bewaar teen of benede 25 °C. Beskerm teen lig.

HOU BUITE BEREIK VAN KINDERS.

REGISTRASIENOMMER

U/11.9/213

Namibia Reg. No.:90/11.9/00623

NS1

Zimbabwe Reg. No.:82/16.6/1575

P

NAAM EN BESIGHEIDSADRES VAN DIE HOUER VAN DIE

REGISTRASIESERTIFIKAAT






of 27 CCDS Dec 2010

JANSSEN PHARMACEUTICA (Pty) Ltd

(Reg. nr. 1980/011122/07)

Gebou 6, Country Club Estate,

Woodlandsrylaan 21, Woodmead, 2191

Tel: +27 (11) 518 7000

www.janssen.co.za

DATUM VAN PUBLIKASIE VAN HIERDIE VOUBILJET

12 Junie 2015

http://www.janssen.co.za/

scheduling status proprietary name and dosage … · strength(s): each capsule contains 2 mg...

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