PATIENT INFORMATION LEAFLET

SCHEDULING STATUS:  S0

CALM YOUR FARM (STRESS RELIEF & SLEEP SUPPORT SACHET)

 

Read this leaflet carefully as it contains important information

Calm Your Farm sachets are available without a doctor’s prescription, for you to treat a mild illness.

Nevertheless, you still need to use Calm Your Farm sachets with caution to get the best results.

  • Keep this leaflet. You may need to read it again.
  • Do not share Calm Your Farm sachets with any other person.
  • Ask your pharmacist if you need further information or advice.
  • You must see a doctor if your symptoms persist.

 

WHAT CALM YOUR FARM CONTAINS

Each 6g sachet contains: 

L-theanine 200mg; Withania somnifera (Ashwagandha) extract 12,5% 100mg; Magnesium bisglycinate equivalent to 750mg elemental magnesium; Melissa officinalis (Lemon Balm) [leaf, as 150 mg of a 5:1 extract providing 750 mg dried herb equivalents]. 

 

PHARMACOLOGICAL ACTION                                               

L-theanine:

Pharmacodynamic properties:

Ingestion of L-theanine affects the concentration of neurotransmitters such as dopamine, serotonin, tryptophan, and γ-aminobutyric acid (GABA). It increases GABA, an inhibitory neurotransmitter to promote sleep. These changes in neurotransmitters in the brain produce anti-stress effects and improved sleep.

Pharmacokinetic properties:

L-theanine is rapidly absorbed in healthy participants after intake of capsules or green tea. The major part of L-theanine seems to be hydrolysed to ethylamine and glutamic acid, which are excreted by urine. A minor part is retained in erythrocytes.

 

Withania somnifera (Ashwagandha) extract:

Pharmacodynamic properties:

Withania root extract and its constituents have been reported to have mild to moderate hypnotic action and antioxidant activity. The sleep-promoting activity of Withania root extract has been linked to allosteric modulation of some of the components of the GABAA receptor supramolecular complex in brain.

Pharmacokinetic properties:

A pharmacokinetic study of withaferin-A (WA), the principle active element of Withania somnifera showed low oral bioavailability of WA and a high first-pass effect due to extensive metabolism by CYP3A4 in the liver. Rapid metabolism of WA in liver microsomes was demonstrated. The peak concentration following oral administration was achieved rapidly but was less than 1% of the maximum concentration achieved through the intravenous route (normalized for dose) indicating low oral availability.

 

Melissa officinalis (Lemon Balm) extract:

Pharmacodynamic properties:

Melissa officinalis (Lemon Balm) is known for its calming and anxiolytic effects, attributed to compounds such as rosmarinic acid, flavonoids, and terpenes. These active components modulate neurotransmitters, particularly gamma-aminobutyric acid (GABA), enhancing its inhibitory effect in the central nervous system.

Melissa officinalis (Lemon Balm) offers several therapeutic benefits, including reducing anxiety and stress, promoting relaxation, and improving sleep quality. It may also have mild spasmolytic effects, helping to relax muscles, and exhibits antioxidant and anti-inflammatory properties, further supporting its role in enhancing overall wellness.

Pharmacokinetic properties:

The active constituents of Melissa officinalis (Lemon Balm), such as rosmarinic acid, are absorbed in the gastrointestinal tract, with bioavailability varying depending on the formulation and dose. Once absorbed, these compounds are distributed systemically, and rosmarinic acid is known to cross the blood-brain barrier, contributing to its central nervous system (CNS) effects. Rosmarinic acid undergoes hepatic metabolism, primarily through conjugation reactions like glucuronidation and sulfation. The metabolites are then excreted through urine and feces, with the elimination half-life generally being short due to rapid metabolism. A 150 mg dose of a 5:1 extract, providing 750 mg of dried herb equivalents, delivers a concentrated dose that supports the herb's anxiolytic and sedative effects, making it beneficial in managing mild to moderate stress, anxiety, and sleep disturbances.

Magnesium bisglycinate:

Pharmacodynamic properties:

Magnesium is a cofactor in enzyme systems that regulates diverse biochemical reactions in the body, including protein synthesis, muscle and nerve function, blood glucose control, and blood pressure. Magnesium is required for energy production, oxidative phosphorylation and glycolysis. Magnesium glycinate has been reported to give rise to rapid recovery of depression. It was found that an inverse correlation exists between magnesium intake and psychiatric states such as anxiety and depression in adults. Magnesium is a natural NMDA receptor antagonist which explains its action as a natural antidepressant. Furthermore, apart from being a natural NMDA antagonist, magnesium is also a GABA agonist, both these biochemical actions give rise to a relaxant effect and facilitate sleep.

Pharmacokinetic properties:

Magnesium homeostasis is maintained by the intestine, the bone and the kidneys. Magnesium is absorbed in the gut, stored in bone mineral and excess magnesium is excreted by the kidneys and in the feces.

 

The inactive ingredients are:

Inulin (Fructooligosaccharides), Acidity Regulator, Red Beetroot Juice Powder (Natural Colourant), Flavouring, Stevia, Anti-Caking Agent. Grape Flavouring.

 

USES FOR CALM YOUR FARM SACHETS

The indications of this product are:

  • Supports maintenance of healthy sleep;
  • Helps to support relaxation; and
  • Contribution to normal functioning of the nervous system

 

Complementary Medicine

Class 33.7 Combination Product

                                                                                                           

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

 

DO NOT TAKE CALM YOUR FARM SACHETS

  • If you have diseases of the heart; gastrointestinal tract; lungs; thyroid; urinary tract; auto-immune diseases; or liver disease.
  • Safety in pregnancy and lactation has not been established. (see PREGNANCY AND LACTATION).

Tell your doctor if you are not sure about any of the above.

 

TAKE SPECIAL CARE WITH CALM YOUR FARM SACHETS

If you have a history of allergic reactions to any of the ingredients. Stop taking this medicine at least two weeks before a scheduled surgery.

 

PREGNANCY AND BREASTFEEING

You should not take Calm Your Farm sachets whilst pregnant or breastfeeding.

 

DRIVING AND USING MACHINERY

Effects on ability to drive are not applicable.

 

Always tell your health care provider if you are taking any other medicine. If you are pregnant or breast feeding, please consult your health care provider for advice before taking this medicine. 

 

Important information about some of the ingredients in Calm Your Farm sachets:

Taking other medicines with Calm Your Farm sachets

If you are taking other medicines on a regular basis, including complimentary or traditional medicines, the use of Calm Your Farm sachets with these medicines may cause undesirable interactions.

 

HOW TO TAKE CALM YOUR FARM SACHETS

  • Do not share medicines with any other person.
  • Place the contents of one sachet (6g) into a glass. Fill with 250ml of water and stir until dissolved. Use 1 daily.

If the condition does not improve within 14 days of use, contact your healthcare practitioner.

Always take Calm Your Farm sachets as indicated or as instructed by your doctor.  You should check with your doctor or pharmacist if you are unsure.

Do not use more than the recommended dose.

 

IF YOU USE MORE CALM YOUR FARM SACHETS THAN YOU SHOULD

In the event of over dosage, consult your doctor or pharmacist.  If neither is available, seek help at the nearest hospital or poison control centre.

 

IF YOU FORGET TO TAKE/MISSED A DOES OF CALM YOUR

Take your missed dose as soon as you remember.  Do not take a double dose to make up for forgotten individual doses.

 

EFFECTS WHEN TREATMENT OF CALM YOUR FARM IS STOPPED

If you use the doses as indicated there should be no adverse effects when stopping use of this medication.

 

POSSIBLE SIDE EFFECTS

Not all side effects reported for Calm Your Farm sachets are included in this leaflet.  Should your general health worsen while taking Calm Your Farm sachets, please consult your doctor, pharmacist or other health care professional for advice. 

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

 

STORAGE AND DISPOSING OF CALM YOUR FARM SACHET

  • Store, at or below 25 °C, away from direct sunlight. 
  • Keep in original packaging until required for use.
  • Do not use after the expiry date stated on the label.
  • Return all unused medicine to your pharmacist.
  • Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets)
  • Keep out of reach of children

 

PRESENTATION OF CALM YOUR FARM SACHET

Purple foil sachet filled with 6g powder.

 

IDENTIFICATION OF CALM YOUR FARM SACHET

Purple powder.

 

REGISTRATION NUMBER

2023 / 886464 / 07

 

HOLDER OF CERTIFICATION OF REGISTRATION

Will be allocated by SAHPRA upon registration. 

DATE OF PUBLICATION OF THE PACKAGE INSERT                                                 

Will be allocated by SAHPRA upon registration.

 

PASIËNTINLIGTINGSBROSJURE

SKEDULERINGSTATUS: S0

OEMPH CALM YOUR FARM (STRESS RIEEF & SLEEP ONDERSTEUNSAKKIES)

 

Lees hierdie pamflet sorgvuldig want dit bevat belangrike inligting.

Calm Your Farm sakkies is beskikbaar sonder 'n voorskrif, vir jou om 'n ligte siektetoestand te behandel.

Jy het egter nodig om Calm Your Farm sakkies noukeurig te gebruik om die beste resultate te kry.

  • Bewaar hierdie pamflet. Jy mag dalk nodig hê om dit weer te lees.
  • Moenie Calm Your Farm deel met enige ander persoon nie.
  • As jy enige addisionele vrae het, vra jou dokter of apteker.
  • Indien die simptome voorduur moet jy jou dokter besoek.

 

HIERDIE MEDISYNE BEVAT:

  • Elke 6g poeier bevat:
  • L-teanine 200mg
  • Withania somnifera (Ashwagandha) ekstrak 12,5% 100mg
  • Magnesium bisglycinate ekwivalent aan 750mg elementele magnesium
  • Melissa officinalis (Suurlemoenbalsem) [blaar, as 150 mg van 'n 5:1-ekstrak wat 750 mg gedroogde kruie-ekwivalente verskaf]

 

 

Die onaktiewe bestanddele is:

Inulien (fruktooligosakkariede), suurreguleerder, rooibeetsappoeier (natuurlik)

Kleurstof), Geurmiddel, Stevia, Anti-koekmiddel. Druiwegeursel.

 

                                                                       

GEBRUIKE VAN CALM YOUR FARM SAKKIES

Hierdie produk is aangedui vir orale gebruik vir 'n verskeidenheid van toestande:

  • Ondersteun normale slaappatrone;
  • Help met ontspanning; en
  • Dra by tot normale funksionering van die senustelsel

 

Gesondheidsaanvulling

Kategorie 34.12 Formulering van meervoudige stowwe;

 

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

 

Moenie CALM YOUR FARM SAKKIES GEBRUIK INDIEN

  • Jy hart, gastrointestinale, long, urinêre, immunologiese of lewer siektes het nie
  • Veiligheid tydens swangerskap en laktasie is nie vasgestel nie. (sien SWANGERSKAP EN LAKTASIE).

Vra jou dokter indien jy nie seker is oor enige van die bogenoemde nie.

 

Gebruik CALM YOUR FARM SAKKIES MET SPESIALE SORG:

As jy ‘n geskiedenis het van allergiese reaksies geassosieer met enige bestanddeel. Stop die gebruik van sakkies ten minste twee weke voor geskeduleerde chirurgie.

 

SWANGERSKAP EN BORSVOEDING

Indien jy swanger is of borsvoed, moet jy nie Calm Your Farm sakkies sonder toesig van jou dokter of apteker gebruik nie.

 

BESTUUR EN GEBRUIK VAN MASJIENE

Dit is onwaarskynlik dat Calm Your Farm sakkies jou vermoë om te bestuur en masjiene te gebruik sal beïnvloed.

  

Belangrike inligting oor 'n paar van die bestanddele in Calm Your Farm sakkies

As jy ander medisyne insluitend komplimentêre of tradisionele medisyne op 'n gereelde basis gebruik, kan die gebruik van Calm Your Farm sakkies ongewenste interaksies met hierdie medisyne veroorsaak. Raadpleeg jou dokter, apteker of professionele gesondheidsorgpraktisyn vir advies.

 

HOE OM CALM YOUR FARM SAKKIES TE NEEM:

  • Moenie medisyne met enige ander person deel nie.
  • Plaas die inhoud van een sakkie (6g) in 'n glas. Vul met 250ml water en roer tot opgelos. Gebruik 1 daagliks.
  • Indien die toestand nie verbeter binne 14 dae van gebruik nie, kontak jou gesondheidsorgpraktisyn.
  • Neem Calm Your Farm sakkies altyd soos aangedui of soos voorgeskryf deur jou dokter. Jy moet die aanwysings met jou dokter of apteker bespreek as jy onseker is. Moenie meer as die aanbevole dosis neem nie.

 

AS JY MEER CALM YOUR FARM SAKKIES NEEM AS JY BEHOORT TE NEEM

Indien jy meer Calm Your Farm sakkies neem as aanbeveel, gesels met jou dokter of apteker daaroor. As jou dokter of apteker nie beskikbaar is nie, soek hulp by die naaste hospitaal or gifbeheersentrum.

 

AS JY VERGEET ON CALM YOUR FARM SAKKIES TE NEEM OF A DOSIS MIS

Neem ‘n dosis wanner jy onthou.  Moenie ‘n dubbele dosis neem om die een wat jy vergeet het, te vervang nie.

 

EFFELKTE WANNER BEHANDELING MET CALM YOUR FARM GESTOP WORD

As jy die dosisse gebruik soos aangedui behoort daar geen nadelige gevolge wees wanneer jy die gebruik van hierdie medikasie stop nie.

 

MOONTLIKE NEWE-EFFEKTE

Nie alle newe-effekte wat gerapporteer is vir Calm Your Farm sakkies is ingesluit in hierdie pamflet nie. Indien jou algemene gesondheid versleg terwyl u Calm Your Farm sakkies gebruik, raadpleeg jou dokter, apteker of ander professionele gesondheidsorgpraktisyn vir advies.

As jy enige newe-effekte ondervind wat nie in hierdie pamflet genoem word nie, stel asseblief jou dokter of apteker in kennis.

 

INLIGTING OOR OPBERGING EN WEGDOENING:

  • Stoor by of onder 25°C, weg van direkte sonlig.
  • Hou die medisyne in die oorspronklike verpakking tot benodig vir gebruik.
  • Moenie gebruik na die verstryking van die vervaldatum op die etiket nie.
  • Gee alle ongebruikte medisyne vir jou apteker.
  • Medisyne behoort nie in rioolwater weggespoel of saam met huishoudelike vullis weggegooi te word nie.
  • Hou buite bereik van kinders.

 

AANBIEDING:

Pers foelie sakkie gevul met 6g poeier.

 

IDENTIFIKASIE:

Pers poeier.

 

REGISTRASIENOMMER:

2023 / 886464 / 07

 

NAAM EN BESIGHEIDSADRES VAN DIE APPLIKANT

Sal by registrasie deur SAHPRA toegeken word.

 

DATUM VAN PUBLIKASIE VAN DIE VOUBILJET                                                 

Sal by registrasie deur SAHPRA toegeken word.