DIGESTIVE ENZYMES

DIGESTIVE ENZYMES

Proposed professional information for DIGESTIVE ENZYMES

COMPLEMENTARY MEDICINE: HEALTH SUPPLEMENT

This unregistered medicine has not been evaluated by SAHPRA for its quality, safety or intended use.

SCHEDULING STATUS

S0

  1. NAME OF THE MEDICINE

DIGESTIVE ENZYMES

  1. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each capsule contains:

Enzyme blend                                                                                   50 mg

(Amylase, protease, lipase, cellulase, lactase).

FoodMatrix® carrot, tomato and spinach extracts                   200 mg

Sugar free.

For the full list of excipients, see section 6.1.

  1. PHARMACEUTICAL FORM

Capsule.

Size 0 clear capsule filled with an off-white powder.

  1. CLINICAL PARTICULARS

4.1             Therapeutic indications

Supporting a healthy digestive system and may assist with absorption of nutrients.

Assists in the digestion of proteins, fats, cellulose and milk sugar.

4.2             Posology and method of administration

One capsule twice daily with the two biggest meals of the day or as prescribed by your healthcare provider. Do not exceed the recommended dosage.

4.3             Contraindications

Hypersensitivity to any of the active ingredients or excipients (see sections 2 and 6.1).

4.4             Special warnings and precautions for use

Consult your healthcare provider before taking DIGESTIVE ENZYMES if you are taking medication or suffering from any medical condition.

4.5             Interaction with other medicines and other forms of interaction

Consult your healthcare provider before taking DIGESTIVE ENZYMES if you are taking medication or suffering from any medical condition.

4.6             Fertility, pregnancy and lactation

Consult your healthcare provider before taking DIGESTIVE ENZYMES if you are pregnant, planning to get pregnant or if you are breastfeeding.

4.7             Effects on ability to drive and use machines

It is not known if DIGESTIVE ENZYMES have an effect on the ability to drive or use machines. Caution is advised before driving a vehicle or operating machinery until the effects of DIGESTIVE ENZYMES are known.

4.8             Undesirable effects

DIGESTIVE ENZYMES is well tolerated.

Reporting of suspected adverse reactions:

Reporting suspected adverse reactions after authorisation of DIGESTIVE ENZYMES is important. It allows continued monitoring of the benefit/risk balance of DIGESTIVE ENZYMES. Healthcare providers are asked to report any suspected adverse reactions to NRF HEALTH via https://www.nrfhealth.co.za

4.9             Overdose

In overdose, side effects can be precipitated and/or be of increased severity (see section 4.8). Overdose treatment is symptomatic and supportive.

  1. PHARMACOLOGICAL PROPERTIES

Category and class: D 34.5 Enzymes.

Lactase is a sugar-splitting enzyme that hydrolyses the milk sugar lactose to glucose and galactose.

Lipase is a digestive enzyme which aids in fat digestion by hydrolysing triglycerides in the stomach and small intestine.

Amylase is an enzyme that catalyses the hydrolysis of starch.

Cellulase is an enzyme which aids in cellulose and polysaccharide digestion.

Protease is an enzyme which breaks down proteins into smaller polypeptides of single amino acids.

  1. PHARMACEUTICAL PARTICULARS

6.1             List of excipients

Magnesium stearate

Microcrystalline cellulose.

6.2             Incompatibilities

Not applicable.

6.3             Shelf life

2 years.

6.4             Special precautions for storage

Store at or below 25 °C.

Protect from light and moisture.

6.5           Nature and contents of container

60 capsules are packed in a white polypropylene securitainer with a red LDPE lid.

6.6             Special precautions for disposal and other handling

None.

  1. HOLDER OF CERTIFICATE OF REGISTRATION

Royal Square 428 Investments (Pty) Ltd

PO Box 1762

Randpark Ridge

2156

  1. REGISTRATION NUMBER

Will be allocated by SAHPRA upon registration.

  1. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Will be allocated by SAHPRA upon registration.

  1. DATE OF REVISION OF THE TEXT

November 2020.

Professionele inligting vir DIGESTIVE ENZYMES

 

KOMPLEMENTÊRE MEDISYNE: GESONDHEIDSAANVULLING

Hierdie ongeregistreerde medisyne is nie vir gehalte, veiligheid of beoogde gebruik deur SAHPRA geëvalueer nie.

 

SKEDULERINGSTATUS

S0

 

  1. NAAM VAN DIE MEDISYNE

DIGESTIVE ENZYMES

 

  1. KWALITATIEWE EN KWANTITATIEWE SAMESTELLING

Elke kapsule bevat:

Ensiemmengsel                                                                                                  50 mg

(Amilase, protease, lipase, sellulase, laktase).

FoodMatrix® wortel-, tamatie- en spinasie-ekstrakte                                    200 mg

Suikervry.

Vir die volledige lys onaktiewe bestanddele, sien afdeling 6.1.

 

  1. DOSEERVORM

Kapsule.

Grootte 0 deurskynende kapsule gevul met ’n naaswit poeier.

 

  1. KLINIESE BESONDERHEDE

4.1             Terapeutiese indikasies

Ondersteuning van ’n gesonde verteringstelsel en mag help met die absorpsie van voedingstowwe.

Help met die vertering van proteïene, vette, sellulose en melksuiker.

 

4.2             Posologie en metode van toediening

Een kapsule twee keer daagliks saam met die twee grootste maaltye van die dag, of soos wat deur jou gesondheidsorgverskaffer voorgeskryf is. Moenie die aanbevole dosis oorskry nie.

 

4.3             Kontra-indikasies

Hipersensitiwiteit vir enige van die aktiewe of onaktiewe bestanddele (sien afdelings 2 en 6.1).

 

4.4             Spesiale waarskuwings en voorsorgmaatreëls vir gebruik

Konsulteer jou gesondheidsorgverskaffer voordat DIGESTIVE ENZYMES geneem word indien jy medikasie neem of aan enige mediese toestand ly.

 

4.5             Interaksies met ander medisyne en ander vorms van interaksie

Konsulteer jou gesondheidsorgverskaffer voordat DIGESTIVE ENZYMES geneem word indien jy medikasie neem of aan enige mediese toestand ly.

 

4.6             Vrugbaarheid, swangerskap en borsvoeding

Konsulteer jou gesondheidsorgverskaffer voordat DIGESTIVE ENZYMES geneem word indien jy swanger is, beplan om swanger te raak of jou baba borsvoed.

 

4.7             Uitwerking op die vermoë om te bestuur en masjiene te gebruik

Dit is onbekend of DIGESTIVE ENZYMES ’n uitwerking het op die vermoë om te bestuur of masjiene te gebruik. Versigtigheid word aangeraai voordat ’n voertuig bestuur of masjinerie hanteer word, totdat bekend is wat die uitwerking van DIGESTIVE ENZYMES is.

 

4.8             Ongewenste effekte

DIGESTIVE ENZYMES word goed verdra.

 

Rapportering van vermoedelike newe-effekte:

Dit is belangrik om vermoedelike newe-effekte wat waargeneem word nadat DIGESTIVE ENZYMES goedgekeur is te rapporteer. Dit help met volgehoue monitering van die voordeel/risiko-balans van DIGESTIVE ENZYMES. Gesondheidsorgverskaffers moet asseblief enige vermoedelike newe-effekte rapporteer aan NRF HEALTH via https://www.nrfhealth.co.za

 

4.9             Oordosering

Met oordosering kan newe-effekte gepresipiteer word en/of ernstiger wees (sien afdeling 4.8). Na oordosering moet simptomatiese en ondersteunende behandeling toegepas word.

 

  1. FARMAKOLOGIESE EIENSKAPPE

Kategorie en klas: D 34.5 Ensieme.

Laktase is ’n ensiem wat suikers splyt, wat die melksuiker laktose na glukose en galaktose hidroliseer.

Lipase is ’n verteringsensiem wat help met die vertering van vette deur die hidrolise van trigliseriede in die maag en dunderm.

Amilase is ’n ensiem wat die hidrolise van stysel kataliseer.

Sellulase is ’n ensiem wat help met die vertering van sellulose en polisakkariede.

Protease is ’n ensiem wat proteïene afbreek na kleiner polipeptiede of na enkel aminosure.

 

  1. FARMASEUTIESE BESONDERHEDE

6.1             Lys van onaktiewe bestanddele

Magnesiumstearaat

Mikrokristallyne sellulose.

 

6.2             Onverenigbaarhede

Nie van toepassing nie.

 

6.3             Rakleeftyd

2 jaar.

 

6.4             Spesiale voorsorgmaatreëls vir berging

Bêre by of onder 25 °C.

Beskerm teen lig en vog.

 

6.5           Aard en inhoud van die houer

60 kapsules word in ’n wit polipropileen-sekuriteitshouer met ’n rooi LDPE-deksel verpak.

 

6.6             Spesiale voorsorgmaatreëls vir wegdoening en ander hantering

Geen.

 

  1. HOUER VAN DIE REGISTRASIESERTIFIKAAT

Royal Square 428 Investments (Edms.) Bpk.

Posbus 1762

Randparkrif

2156

 

  1. REGISTRASIENOMMER

Sal met registrasie deur SAHPRA toegeken word.

 

  1. DATUM VAN EERSTE MAGTIGING/HERNUWING VAN MAGTIGING

Sal met registrasie deur SAHPRA toegeken word.

 

  1. DATUM VAN HERSIENING VAN DIE TEKS

November 2020.

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