SCHEDULING STATUS

S0

PROPRIETARY NAME AND DOSAGE FORM

Hormone Capsules

COMPOSITION

Excipients: veggie capsules

Sugar Free

CATEGORY AND CLASS

Category D: Complementary Medicine

Class 33.7 Combination Product

PHARMACOLOGICAL ACTION

Pharmacological Action

The Pharmacological action is achieved by the combination of ingredients to promote healthy mood balance.

Pharmacokinetic Properties

The active ingredients in this formulation are well known. Pharmacokinetic studies have not been conducted on Hormone Capsules.

INDICATIONS

• Used in Herbal Medicine to help relieve premenstrual symptoms
• Used in Herbal Medicine as a hormone normalizer, to help stabiles menstrual cycle irregularities.
• Used in Herbal Medicine to help relieve symptoms associated with menopause, such as hot flushes.
• Used in Herbal Medicine to help promote healthy mood balance and relieve sleep disturbances associated with mood imbalance.
• A factor in the maintenance of good health.

WARNINGS AND SPECIAL PRECAUTIONS

Consult a health care practitioner:

• if symptoms persist or worsen.
• prior to use if you are taking medications for diabetes, high blood pressure, seizures, anxiety, antihistamines, bronchodilators, muscle relaxants and opiates.
• prior to use if you are pregnant or breastfeeding.
• prior to use if you are taking hormone-containing medications such as progesterone preparations, oral contraceptives or hormone replacement therapy.

Avoid taking with alcohol or products that cause drowsiness.

Avoid prolonged exposure to sunlight, ultraviolet light (UV) or UV therapy.

In general, health supplements should not be intended for supply to any children under the age of seven (7) months old unless where supplementation is medically warranted.

INTERACTIONS

Hormone can interact with other medications such as:

• anti-cancer medicines
• antidepressants (such as selective serotonin reuptake inhibitors)
• cardiovascular
• contraceptives
• blood thinners
• Anti-HIV agents
• Immunosuppressives

Do not use this product if you are taking health products that affect blood coagulation as this may increase the risk of spontaneous bleeding.

HUMAN REPRODUCTION

Consult a health care practitioner prior to use if you are pregnant, intending on becoming pregnant or breastfeeding.

DOSAGE AND DIRECTIONS FOR USE

Adults 18 years and older:

Take one capsule once daily or as directed by a health care practitioner.

Use for at least 3 months to see beneficial effects. Consult a health care practitioner for use beyond 18 weeks.

SIDE EFFECTS

Adverse reactions are listed below by system organ class and by frequency. 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), according to the MedDRA frequency convention and system organ classification.

Immune system disorders

Frequency unknown

Hypersensitivity reaction (such as rash)

Nausea, restlessness and headaches

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the “6.04 Adverse Drug Reactions Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8.

CONTRAINDICATIONS

Hypersensitivity/allergy to any of the ingredients, in which case, discontinue use.

If you are taking any of the following medications:

• anti-cancer medicines
• antidepressants (such as selective serotonin reuptake inhibitors)
• cardiovascular
• contraceptives
• blood thinners
• Anti-HIV agents
• Immunosuppressives
• health products that affect blood coagulation as this may increase the risk of spontaneous bleeding.

KNOWN SYMPTOMS OF OVER-DOSAGE AND PARTICULARS OF ITS TREATMENT

See section Warnings and Special Precautions and Side Effects.

In overdose, side effects can be precipitated and/or be of increased severity.

Treatment should be symptomatic and supportive.

IDENTIFICATION

Clear, size 00 capsule filled with brown powder.

PRESENTATION

Clear, glass jar with aluminium screw lid.

STORAGE INSTRUCTIONS

Store in a dark, dry place at or below 25˚C.

REGISTRATION NUMBER

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

DATE OF PUBLICATION

February 2022

AFRIKAANS

SKEDULERINGSTATUS:

S0

BENAMING EN DOSERINGVORM:

Hormone capsules

SAMESTELLING:

Hulpstowwe: groente-kapsules

Suikervry

KATEGORIE EN KLAS

Kategorie D: Aanvullende medisyne

Klas 33.7 Kombinasieproduk

FARMAKOLOGIESE AKSIE:

Farmakologiese aksie

Die farmakologiese werking word bewerkstellig deur die kombinasie van bestanddele om gesonde gemoedbalans te bevorder.

Farmakokinetiese eienskappe

Die aktiewe bestanddele in hierdie formulering is bekend. Farmakokinetiese studies is nie op Hormone Capsules uitgevoer nie.

AANWYSINGS

• Word gebruik in Kruie Geneeskunde om voormenstruele simptome te verlig
• Word gebruik in Kruie Geneeskunde as ‘n hormoonnormaliseerder om onreëlmatighede in die menstruasie-siklus te verminder.
• Word gebruik in Kruie Geneeskunde om simptome wat verband hou met menopouse te verlig, soos warm gloede.
• Word gebruik in Kruie Geneeskunde om ‘n gesonde gemoedbalans te bevorder en slaapstoornisse wat verband hou met gemoedwanbalans te verlig.
• ‘n Faktor in die handhawing van goeie gesondheid.

WAARSKUWINGS EN SPESIALE VOORSORGMAATREËLS

Raadpleeg ‘n geneesheer:

• as simptome voortduur of vererger.
• voor gebruik as u medikasie neem vir diabetes, hoë bloeddruk, aanvalle, angs, antihistamiene, brongodilatore, spierverslappers en opiate.
• voor gebruik as u swanger is of borsvoed.
• voor gebruik as u hormoonbevattende medikasie neem, soos progesteroonpreparate, orale voorbehoedmiddels of hormoonvervangingsterapie.

Vermy alkohol of produkte wat slaperigheid veroorsaak.

Vermy langdurige blootstelling aan sonlig, ultraviolet lig (UV) of UV-terapie.

Oor die algemeen moet gesondheidsaanvullings nie bedoel wees vir verskaffing aan kinders onder die ouderdom van sewe (7) maande nie, tensy dit medies geregverdig is om aanvulling te kry.

INTERAKSIES

Hormone kan interaksie hê met ander medikasie soos:

• medisyne teen kanker
• antidepressante (soos selektiewe serotonienheropname-remmers)
• kardiovaskulêre middels
• voorbehoedmiddels
• bloedverdunners
• Anti-MIV-agente
• Immunosuppressiewe middels

Moenie hierdie produk gebruik as u gesondheidsprodukte neem wat die bloedstolling beïnvloed nie, aangesien dit die risiko van spontane bloeding kan verhoog.

MENSLIKE REPRODUKSIE

Raadpleeg ‘n geneesheer voor gebruik as u swanger is, die doel het om swanger te raak of borsvoed.

DOSIS EN AANWYSINGS VIR GEBRUIK

Volwassenes van 18 jaar en ouer:

Neem een kapsule een keer per dag of soos aangedui deur ‘n geneesheer.

Gebruik ten minste 3 maande om voordelige gevolge te sien. Raadpleeg ‘n geneesheer vir gesondheidsorg vir gebruik langer as 18 weke.

NEWE-EFFEKTE

Die newe-reaksies word hieronder gelys volgens die orgaanklas en volgens frekwensie. Frekwensies word gedefinieer as: Baie gereeld (≥1 / 10), algemeen (≥ 1/100, <1/10), ongewoon (≥1 / 1, 000, <1/100), skaars (≥1 / 10,000, <1/1, 000), baie skaars (<1/10,00000) volgens die MedDRA frekwensie-konvensie en stelselorgaanklassifikasie..

Immuunstelsel-afwykings

Frekwensie onbekend

Hipersensitiwiteitsreaksie (soos uitslag)

Naarheid, rusteloosheid en hoofpyn

Verslagdoening oor vermoedelike newe-reaksies

Dit is belangrik om vermoedelike newe-reaksies na die magtiging van die medisyne aan te meld. Dit laat voortgesette monitering van die voordeel / risiko-balans van die medisyne toe. Verskaffers van gesondheidsorg word gevra om enige vermoedelike nadelige reaksies by SAHPRA aan te meld via die “6.04 Nadelige medisyne-verslagdoeningsvorm”, wat aanlyn gevind word onder SAHPRA se publikasies: https: //www.sahpra.org.za / Publikasies / Indeks / 8.

KONTRA-INDIKASIES

Oorgevoeligheid / allergie vir enige van die bestanddele, in welke geval die gebruik gestaak word.

As u een van die volgende medikasie neem:

• medisyne teen kanker
• antidepressante (soos selektiewe serotonienheropname-remmers)
• kardiovaskulêre middels
• voorbehoedmiddels
• bloedverdunners
• Anti-MIV-agente
• Immunosuppressiewe middels
• gesondheidsprodukte wat bloedstolling beïnvloed, aangesien dit die risiko van spontane bloeding kan verhoog.

BEKENDE SIMPTOME VAN OOR-DOSERING EN BESONDERHEDE VAN BEHANDELING

Sien afdeling Waarskuwings en spesiale voorsorgmaatreëls en newe-effekte.

By oordosis kan newe-effekte versnel word en / of vererger word.

Behandeling moet simptomaties en ondersteunend wees.

IDENTIFIKASIE

Helder, grootte 00 kapsule gevul met bruin poeier.

AANWYSING

Helder, glaskruik met aluminiumskroefdeksel.

BERGINGSINSTRUKSIES

Berg in ‘n donker, droë plek by of onder 25˚C

REGISTRASIENOMMER

Hierdie ongeregistreerde medisyne is nie deur die SAHPRA geëvalueer vir die kwaliteit daarvan, veiligheid of beoogde gebruik nie.

DATUM VAN PUBLIKASIE

Februarie 2022