1
I11I Albenda Tablets, Suspension Broad-Spectrum Anthelmentic - Composrtron Tablets Each tablet contains: Active ingredient: Albendazole 200mg Excipients: Starch, lactose, cross linked starch, povidone. saccharin sodium. polysorbate. cellulose. vanilla and blood orange flavours. stearic acid, magnesium stearate, aerosil, sodium lauryl sulfate, hypromellose, talc, titanium dioxide, and polyethylene glycol, Suspension , Each teaspoonful (5mL) of the suspension contains: Active ingredient: Albendazole 100mg Excipients: Saccharin sodium, potassium sorbate. propylene glycol, xanthan gum, lrult flavour. polysorbate. cunc acid, vantl!a and blood orange flavours, and purified water. - - - Properties Albendazole, the acuve ingredient of Albenda. a oenzirnidaz Ie carbonate anthelmentic, is a broad spectrum vermicidal and for most helminths. an ovicidal and larvicidal. It is ac e against the parasite in all its stages,Although its mechanism of action is not yet completely known, It seems to act by selectve degeneration of cytoplasmic microtubules of the Intes nal cells thereby impairing glucose uptake and choline-esterase secretion and causing energy deptetion which Immobilizes and kills the parasite. ,, Albendazole is poorly absorbed after oral adrninistranoo and it undergoes extensive first-pass metabolism to proooce an active sunoxioe metabolite, w' IS eh a If' he urine with other minor metabolites. Albendazole sultoxide is approximately 70% protein bound and Its ha'- 'e IS8,5 hours, lncrcanons Albenda is effective against a variety of i 'e a: nematodes, cestodes and trematodes' mtestatrons .ociuo ng Enterobiasis (pinworms or threadworms) Tr cnunas s (wnipworms), Ascariasis (large roundworms), Stronqykndrasis (small roundworms), Taeniasis (tapeworms). hoo worm Infections (Ancylostoma and Necator) and tnfestations of some species of liver flukes, It has been designated an orphan product for use in the treatment of hydatid disease and neurocysticercosis. - Josag" Adults and children over 2 years of age' 1 Enterobrasis ascanasis, r.chunasls, trlchostronqynasrs and hookworm mtecnons. 400mg as a single dose 'f remtecuon occurs after 3 weeks touow-up, the treatmen may be repeated 2, Strcnqylordrasis and taeniasis: 400mg as a Single dose for three days, 3, Hydatid disease: Adults 60 kg or above: 400mg twice a day with meals for 28 days followed by 14 albendazole-free days: up to 3 cycles may be given , Adults below 60 kg: 15mglkgday In civrceo doses twice a day with meals for the same period above: maximum total daily dose should not exceed 800mg 4, Neurocysucercosrs: Same dosage as In case a hydatid disease but the duration of therapy IS 8-30 days 0312891C If you missed 8 dose Take the missed dose as soon as possible, Skip the missed dose if it is almost time for your next regular dose, , Do not take two doses at the same time, c ontramdrcanons Administration in patients with hypersensitivity to the benzimidazole drug class is not recommended, In pregnancy, albendazole is better to be avoided due to teratogenic results in laboratory animals, Precautions In pinworm infections, the whole family Should be careful and might need to administer the medicine, , If the helminth is a hookworm or a whipworm. I IS advisable to take iron supplements, , , It is advised to use an effective form of birth control while taktng this rnedicrne and for at least one month after your last dose, Caution is recommended in lactating women Since albendazole may cause a reduction In total white cell counts and an elevation in hepatic enzymes with prolonged use, it is recommended that blood counts and liver function tests be carned out at the beginning of each 28·day cycle of therapy. and every 2 weeks during therapy; re-treatment with albendazole should not be initiated if significant depression In total white cell counts or elevation in liver enzymes persists, Patients With a hrs ory 0 hver disease or currently have liver problems may need specral care, Overdosage In the animals, symotoms were demonstrated in a dose- response relationsh p and mcluceo diarrhea, vornrtmq, tachycardia, and respraro-y distress, , In case of overdosage. symptomatic therapy (e.q. gastnc lavage and activated c arcoat) and general supportive measures are recommenced. E Serr-e pal" a ts may experience nausea, vomiting, stomach a dizziness, and headache, Or e ac Ions Co-ac= ration of cimetidine. praziquantel. or dexameu asone with albendazole seems to Increase the rs of albendazole Side effects, P ese allons Albenda tablets: Pack of 2 tablets, Albenda suspension: Bottle of 20mL • Store at a temperature 0 15 - 25 C. THIS IS A MEOICAMENT - MeOtea"'e,..· s a product wn,ch euects )our trea t~ and us ccr-sc-ecncn contra,)' to inSauctions -s dal'\gerou$ lor fOU - Follow StlJC1 J ""\e OOC\O,-S prescocucn the metnoc of use and...lbf. ,"sl'u<:11Q!"S ot the cnacnecar ..••• hO-soJd the mechcan-enl - "':'t-e ceerc- and the pharmaCistall! e eoeus .1"\ eece.ees the., bef'e',·s and ,.s\..s Dc"~ bf yoursellll'1lertupl Il'Iepet.OCl Of Irea'trent £)r@SCI>Oed for you - Do "0' repeat the same prescr o:.o~ .••• 11"Or..' cer.~~~ ,'Oufooctor - «eec an medicaments 0U101 the-reec- o! _ Council 01 Arab Heallh III n.s'ecl"S Union 01Arab Pharrn.ac s s r tcrmeuon? Call Toll Free 71)800·4994 Produced by J,,,ilf Gcn Pharmacet.·.c.a -ocse es 'Qs.c,"'-t\a a" oJ AE 04'05,2006 pharmacia pharmacia pharmacia

Albenda Tablet & Suspension Patirnt Information Leafleat-signed

Embed Size (px)

DESCRIPTION

النشرة الداخلية

Citation preview

Page 1: Albenda Tablet & Suspension Patirnt Information Leafleat-signed

I11IAlbendaTablets, SuspensionBroad-Spectrum Anthelmentic

-

ComposrtronTabletsEach tablet contains:Active ingredient: Albendazole 200mgExcipients: Starch, lactose, cross linked starch, povidone.

saccharin sodium. polysorbate. cellulose.vanilla and blood orange flavours. stearic acid,magnesium stearate, aerosil, sodium laurylsulfate, hypromellose, talc, titanium dioxide, andpolyethylene glycol,

Suspension ,Each teaspoonful (5mL) of the suspension contains:Active ingredient: Albendazole 100mgExcipients: Saccharin sodium, potassium sorbate.

propylene glycol, xanthan gum, lrult flavour.polysorbate. cunc acid, vantl!a and blood orangeflavours, and purified water.--- Properties

Albendazole, the acuve ingredient of Albenda. a oenzirnidaz Iecarbonate anthelmentic, is a broad spectrum vermicidal andfor most helminths. an ovicidal and larvicidal. It is ac eagainst the parasite in all its stages,Although its mechanism ofaction is not yet completely known, It seems to act by selectvedegeneration of cytoplasmic microtubules of the Intes nalcells thereby impairing glucose uptake and choline-esterasesecretion and causing energy deptetion which Immobilizes andkills the parasite. , ,Albendazole is poorly absorbed after oral adrninistranoo andit undergoes extensive first-pass metabolism to prooocean active sunoxioe metabolite, w' IS eh a If' he

urine with other minor metabolites. Albendazole sultoxide isapproximately 70% protein bound and Its ha'- 'e IS 8,5 hours,

lncrcanonsAlbenda is effective against a variety of i 'e a: nematodes,cestodes and trematodes' mtestatrons .ociuo ng Enterobiasis(pinworms or threadworms) Tr cnunas s (wnipworms),Ascariasis (large roundworms), Stronqykndrasis (smallroundworms), Taeniasis (tapeworms). hoo worm Infections(Ancylostoma and Necator) and tnfestations of some speciesof liver flukes,It has been designated an orphan product for use in thetreatment of hydatid disease and neurocysticercosis.

-

Josag"Adults and children over 2 years of age'1 Enterobrasis ascanasis, r.chunasls, trlchostronqynasrs

and hookworm mtecnons. 400mg as a single dose 'fremtecuon occurs after 3 weeks touow-up, the treatmenmay be repeated

2, Strcnqylordrasis and taeniasis: 400mg as a Single dosefor three days,

3, Hydatid disease:Adults 60 kg or above: 400mg twice a day withmeals for 28 days followed by 14 albendazole-freedays: up to 3 cycles may be given ,Adults below 60 kg: 15mglkgday In civrceo dosestwice a day with meals for the same period above:maximum total daily dose should not exceed800mg

4, Neurocysucercosrs: Same dosage as In case a hydatiddisease but the duration of therapy IS 8-30 days

0312891CIf you missed 8 doseTake the missed dose as soon as possible,Skip the missed dose if it is almost time for your nextregular dose, ,Do not take two doses at the same time,

c ontramdrcanonsAdministration in patients with hypersensitivity to thebenzimidazole drug class is not recommended,In pregnancy, albendazole is better to be avoided due toteratogenic results in laboratory animals,

PrecautionsIn pinworm infections, the whole family Should be careful andmight need to administer the medicine, ,If the helminth is a hookworm or a whipworm. I IS advisable totake iron supplements, , ,It is advised to use an effective form of birth control while taktngthis rnedicrne and for at least one month after your last dose,Caution is recommended in lactating womenSince albendazole may cause a reduction In total white cellcounts and an elevation in hepatic enzymes with prolongeduse, it is recommended that blood counts and liver functiontests be carned out at the beginning of each 28·day cycle oftherapy. and every 2 weeks during therapy; re-treatment withalbendazole should not be initiated if significant depression Intotal white cell counts or elevation in liver enzymes persists,Patients With a hrs ory 0 hver disease or currently have liverproblems may need specral care,

OverdosageIn the animals, symotoms were demonstrated in a dose-response relationsh p and mcluceo diarrhea, vornrtmq,tachycardia, and respraro-y distress, ,In case of overdosage. symptomatic therapy (e.q. gastnclavage and activated c arcoat) and general supportivemeasures are recommenced.

ESerr-epal" a

ts may experience nausea, vomiting, stomacha dizziness, and headache,

Or e ac IonsCo-ac= ration of cimetidine. praziquantel. ordexameu asone with albendazole seems to Increase the rsof albendazole Side effects,

P ese allonsAlbenda tablets: Pack of 2 tablets,Albenda suspension: Bottle of 20mL

• Store at a temperature 0 15 - 25 C.

THIS IS A MEOICAMENT

- MeOtea"'e,..· s a product wn,ch euects )our trea t~and us ccr-sc-ecncn contra,)' to inSauctions -sdal'\gerou$ lor fOU

- Follow StlJC1 J ""\e OOC\O,-S prescocucn the metnocof use and...lbf. ,"sl'u<:11Q!"S ot the cnacnecar ..•••hO-soJdthe mechcan-enl

- "':'t-e ceerc- and the pharmaCist all! e eoeus .1"\eece.ees the., bef'e',·s and ,.s\..sDc"~ bf yoursellll'1lertupl Il'Iepet.OClOf Irea'trent£)r@SCI>Oed for you

- Do "0' repeat the same prescr o:.o~ .•••11"Or..'cer.~~~,'Oufooctor

- «eec an medicaments 0U101 the-reec- o! _

Council 01 Arab Heallh IIIn.s'ecl"SUnion 01 Arab Pharrn.ac s s

r tcrmeuon? Call Toll Free 71)800·4994

Produced by J,,,ilfGcn Pharmacet.·.c.a -ocse es'Qs.c,"'-t\a a" oJ A E

04'05,2006

pharmacia

pharmacia

pharmacia