Microsoft word - gelusil-s approved.doc

GELUSIL-S

SCHEDULING STATUS:

S0
PROPRIETARY NAME (AND DOSAGE FORM):

Gelusil-S (tablet)
COMPOSITION:

Each tablet contains:
Simethicone (activated methylpolysiloxane)
PHARMACOLOGICAL CLASSIFICATION:

A: 11.4.1 Antacids - Acid neutralisers.
PHARMACOLOGICAL ACTION:

Gelusil-S is a combination of two antacids, aluminium hydroxide and magnesium hydroxide plus a
defoaming agent, simethicone. This component breaks down barriers of foaming mucus thereby
providing effective anti-flatulent action.
INDICATIONS:

For the relief of hyperacidity and flatulence associated with heartburn, gastritis and acid indigestion,
and as adjunctive treatment in peptic ulcers.
CONTRA-INDICATIONS:

Sensitivity to any of the ingredients. Impaired renal function.
DOSAGE AND DIRECTIONS FOR USE:

Adults:
One or two tablets chewed or allowed to disintegrate in the mouth 4 to 8 times a day, preferably
between meals, or as directed by a doctor. Do not take more than 16 tablets in a 24 hour period.
Do not use the maximum dosage of this product for more than 2 weeks, except under the advice or supervision of a doctor.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:

Aluminium hydroxide may cause nausea, vomiting and constipation. Large doses can cause intestinal obstruction. Aluminium hydroxide in patients with low-phosphate diets may lead to phosphate depletion accompanied by increased resorption and urinary excretion of calcium with the risk of osteomalacia. Osteomalacia, and also encephalopathy and dementia, have occurred in patients with chronic renal failure who received relatively high doses of aluminium hydroxide as a phosphate-binding agent. Magnesium may cause diarrhoea. Although magnesium is poorly absorbed following oral administration, hypermagnesaemia has occurred after the excessive use of magnesium-containing antacids and especially in renal insufficiency. Symptoms may include flushing of the skin, thirst,
hypotension due to peripheral vasodilatation, drowsiness, confusion, loss of tendon reflexes due to
neuromuscular blockade, muscle weakness, respiratory depression, cardiac arrhythmias, coma, and
cardiac arrest.
Interactions:
Gelusil-S used concurrently with oral tetracyclines, digoxin, oral iron preparations, anticholinergic
drugs, barbiturates, quinines, quinidine, warfarin, vitamins, H2-receptor antagonists, oral isoniazid, sucralfate, sodium fluoride, ketoconazole, phenytoin, phenothiazines and methenamine may reduce the absorption of these agents. In general, patients should be advised not to take any oral medication within at least 2 hours of taking antacids. KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:

See Side-effects and Special precautions.
Treatment: Symptomatic and supportive.
IDENTIFICATION:

A white, round, bevel-edged tablet with a lemon-spearmint odour and taste.
PRESENTATION:

Blisters of 16 and 24 tablets.
STORAGE INSTRUCTIONS:

Store in a cool (below 25°C), dry place. KEEP OUT OF REACH OF CHILDREN.
REGISTRATION NUMBER:

E/11.4.1/633
NAME AND BUSINESS ADDRESS OF APPLICANT:

Pharma Dynamics (Pty) Ltd.
F02 Grapevine House,
Steenberg Office Park,
Westlake,
7945
DATE OF PUBLICATION OF THIS PACKAGE INSERT:

24 March 1993.
GELUSIL-S

SKEDULERINGSTATUS:

S0
EIENDOMSNAAM (EN DOSERING VORM):

Gelusil-S (tablet)
SAMESTELLING:

Elke tablet bevat:
Simetikoon (geaktiveerde metielpolisiloksaan) 20 mg
(Magnesium inhoud: 3,4 mmol per tablet)
FARMAKOLOGIESE KLASSIFIKASIE:

A: 11.4.1 Teensure - Suurneutraliseerders.
FARMAKOLOGIESE WERKING:

Gelusil-S is 'n kombinasie van twee teensuurmiddels, aluminiumhidroksied en magnesiumhidroksied
tesame met 'n teenskuimmiddel, simetikoon. Hierdie komponent breek skuimskanse van slym af,
met gevolglike effektiewe werking teen winderigheid.
INDIKASIES:

Vir die verligting van oormatige suur en opgeblasenheid geassosieer met sooibrand, gastritis en
slegte spysvertering , en as bykomstige behandeling by peptiese ulkusse.
KONTRA-INDIKASIES:

Sensitiwiteit vir enige van die bestanddele. Beskadigde nierfunksie.
DOSIS EN GEBRUIKSAANWYSINGS:

Volwassenes:
Een of twee tablette gekou of opgelos in die mond 4 tot 8 maal per dag, verkieslik tussen maaltye, of
soos voorgeskryf deur 'n geneesheer. Moet nie meer as 16 tablette in ‘n 24 uur periode inneem nie.
Moet nie die maksimum dosis van hierdie produk vir meer as 2 weke gebruik nie, behalwe op
aanbeveling of onder toesig van 'n geneesheer.
NEWE-EFFEKTE EN SPESIALE VOORSORGMAATREëLS:

Aluminiumhidroksied kan naarheid, vomering en konstipasie veroorsaak. Groot dosisse kan
intestinale obstruksie veroorsaak. By pasiënte wat op laefosfaatdiëte is, kan aluminium lei tot
fosfaatuitputting wat met verhoogde resorpsie en urinêre uitskeiding van kalsium gepaard gaan, en
die risiko van osteomalasie. Osteomalasie, sowel as enkefalopatie en demensie, het al voorgekom
in pasiënte met chroniese nierversaking wat relatief hoë dosisse aluminiumhidroksied as 'n
fosfaatbinder ontvang het.
Magnesium kan diaree veroorsaak. Alhoewel die absorpsie van magnesium na mondelikse
toediening swak is, het hipermagnesemie al na oormatige gebruik van teensuurmiddels wat
magnesium bevat, en veral in die geval van renale ontoereikenheid, voorgekom. Simptome kan
velgloede, dors, hipotensie weens perifere vasodilasie, lomerigheid, verwarring, verlies van
tendonreflekse as gevolg van neuromuskulêre versperring, spierswakheid, respiratoriese
onderdrukking, kardiale aritmies, koma en kardiale arres insluit.
Interaksies:
Gelyktydige gebruik van Gelusil-S met mondelike tetrasikliene, digoksien, mondelike ysterpreparate,
anticholinergiese geneesmiddels, barbiturate, kinien, kinidien, warfarien, vitamiene, H2-reseptor-antagoniste, mondelike isoniasied, sukralfaat, natriumfluoried, ketokonasool, fenitoïen, fenotiasiene en metenamien kan die absorpsie van hierdie middels verminder. In die algemeen behoort pasiënte aangeraai te word om geen ander mondelike medikasie binne minstens 2 ure nadat teensure gebruik is, in te neem nie. BEKENDE SIMPTOME VAN OORDOSERING EN BESONDERHEDE VAN DIE BEHANDELING
DAARVAN:

Sien Newe-effekte en Spesiale voorsorgmaatreëls.
Behandeling: Simptomaties en ondersteunend.
IDENTIFIKASIE:

'n Wit, rond, afgeskuinste tablet met 'n suurlemoen-groenmentgeur en -smaak.
AANBIEDING:

Stulpverpakkings met 16 en 24 tablette.
BERGINGSINSTRUKSIES:

Bewaar op 'n koel (benede 25ºC), droë plek. HOU BUITE BEREIK VAN KINDERS.
REGISTRASIENOMMER:

E/11.4.1/633
NAAM EN BESIGHEIDSADRES VAN APPLIKANT:

Pharma Dynamics (Edms) Bpk.
F02 Grapevine House,
Steenberg Office Park,
Westlake,
7945
DATUM VAN PUBLIKASIE VAN HIERDIE VOUBILJET:

24 Maart 1993.

Source: http://www.mkem.co.za/userfiles/file/Gelusil-s.pdf