PATIENT INFORMATION LEAFLET
Scheduling status [S0]
Soaring Free Lion’s Mane capsules (vegetable capsule)
Category D33.4 Traditional Chinese Medicine. Complementary Medicine. Health Supplement. Vitamin supplements should not replace a balanced diet. A varied diet is the most effective and safe way to achieve good nutrition, health, body composition as well as mental and physical performance.
Read this entire leaflet carefully before you start using Lion's Mane Capsules, as it contains important information for you.
Lion's Mane Capsules is available without a doctor’s prescription for you to help support and maintain your health. Nevertheless, you still need to use Lion's Mane Capsules carefully and responsibly to get the best results.
• It is suggested to keep this information on hand in case you need to refer to it again.
• If you have any further questions, ask your healthcare provider.
• Do not share Lion's Mane Capsules with any other person.
• If any of the side effects becomes serious, or if you notice any side effects not listed in this leaflet, please consult your healthcare provider.
In this leaflet:
1. What is Lion's Mane Capsules and what it is used for.
2. What you need to know before you take Lion's Mane Capsules.
3. How to take Lion's Mane Capsules.
4. Possible side effects.
5. How to store Lion's Mane Capsules.
6. Contents of the pack and other information.
1. WHAT LION'S MANE CAPSULES IS AND WHAT
IT IS USED FOR
Lion's Mane Capsules are a dietary supplement in capsule form used to support cognitive health and overall wellbeing. It belongs to the category of complementary medicines.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE LION'S MANE CAPSULES
Do not use Lion's Mane Capsules if you:
- Are allergic or if you have a known hypersensitivity to any of the ingredients (see 6. CONTENTS OF THE PACK AND OTHER INFORMATION).
- Have any known sensitivity to mushroom products.
Warnings and precautions:
- Talk to your doctor or pharmacist before taking Lion's Mane Capsules if you have any medical conditions.
- This product is not intended to diagnose, treat, cure, or prevent any disease.
Children and adolescents:
- Lion's Mane Capsules are not recommended for children under 18 years without medical advice. Lion’s Mane mushroom is generally considered safe, but further studies are needed to support this.
Other medicines and Lion's Mane Capsules:
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including over the counter medicines and complementary medicines. Please take note of the following:
2. Hypoglycemic Medications: Lion's Mane has been reported to have blood sugar-lowering effects. Therefore, individuals taking medications for diabetes, such as insulin or oral hypoglycemic agents (e.g., metformin), may experience an enhanced blood sugar-lowering effect, increasing the risk of hypoglycemia.
3. Immunosuppressants: Some studies suggest that Lion's Mane may have immunomodulatory effects. For individuals taking immunosuppressive drugs, such as those used after organ transplantation or for autoimmune diseases (e.g., cyclosporine, tacrolimus), Lion's Mane could potentially interfere with the intended immune suppression.
4. Antihypertensive Drugs: Due to the potential for Lion's Mane to lower blood pressure, individuals taking antihypertensive medications (e.g., ACE inhibitors, beta-blockers) may experience an additive blood pressure-lowering effect, leading to hypotension.
5. Medications Metabolized by Cytochrome P450 Enzymes: Lion's Mane may affect the activity of liver enzymes involved in drug metabolism (particularly CYP1A2, CYP2D6, and CYP3A4). This could alter the levels and efficacy of various medications metabolized by these enzymes, such as certain antidepressants, antiepileptics, and statins.
Pregnancy and breastfeeding:
- If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before taking this medicine.
Driving and using machines:
- There are no known effects of Lion's Mane mushroom on the ability to drive or use machines.
3. HOW TO USE LION'S MANE CAPSULES
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Dosage:
- Adults: Take 4 capsules in the morning.
Method of administration:
- Take Lion's Mane Capsules with water, with or without food.
If you take too many Lion's Mane Capsules:
(See 4. POSSIBLE SIDE EFFECTS)
- In the event of overdosage, contact your doctor or pharmacist. If neither are available, contact the nearest hospital or poison centre..
If you forget to take Lion's Mane Capsules:
- Take it as soon as you remember. Do not take a double dose to make up for a forgotten dose.
4. POSSIBLE SIDE EFFECTS
Lion's Mane Capsules can have side effects. Not all side effects are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking Lion's Mane Capsules, please consult with your healthcare provider for advice.
Common side effects:
- None reported.
Uncommon side effects:
- Gastrointestinal discomfort (e.g., nausea, stomach cramps)
- Diarrhea
- Skin rash or itching (allergic reactions)
- Breathing difficulties (in rare cases, due to allergic reactions)
- Dizziness
- Blood thinning effects (increased risk of bleeding)
- Hypoglycemia (low blood sugar)
Reporting of side effects:
- If you have any side effects, talk to your doctor or pharmacist. You can also report side effects to SAHPRA via the ‘6.04 Adverse Drug Reaction Reporting Form’, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of Lion's Mane Capsules.
5. HOW TO STORE SOARING FREE LION'S MANE CAPSULES
- KEEP OUT OF REACH OF CHILDREN.
- Store in a cool, dry place below 25°C and away from direct sunlight.
- Do not use this medicine after the expiry date stated on the packaging.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Lion's Mane Capsules contain:
- The active ingredient is Lion's Mane mushroom (Hericium erinaceus) dried powder.
- The capsule is made from Hydroxypropyl Methylcellulose (vegetable cellulose).
- No other ingredients are added.
What Lion's Mane Capsules look like and contents of the pack:
- Lion's Mane Mushroom Capsules are provided in an amber glass bottle and silver metal lid with 90 vegecaps.
Manufacturer:
- Soaring Free, 11 The Village, Capricorn Drive, Capricorn Park, Muizenberg, 7548
- Tel: 0861 000 976
- Email: info@superfoods.co.za
THIS LEAFLET WAS LAST REVISED ON
September 2024
REGISTRATION NUMBER
Will be allocated by SAHPRA upon registration.
ACCESS TO THE CORRESPONDING PROFESSIONAL INFORMATION
For further information refer to the Professional Information of the product which can be found at superfoods.co.za.
This unregistered medicine has not been evaluated by the SAHPRA for its quality, safety and intended use. This supplement is not intended to diagnose, treat, cure, or prevent any disease.
PASIËNT INLIGTINGSBRIEF
Skeduleringstatus [S0]
Soaring Free Lion's Mane Kapsules (groentekapsule)
Kategorie D33.4 Tradisionele Chinese Geneeskunde. Komplementêre medisyne. Gesondheidsaanvulling. Vitamienaanvullings behoort nie 'n gebalanseerde diëet te vervang nie. ’n Gevariëerde diëet is die mees doeltreffende en veiligste manier om goeie voeding, gesondheid, liggaamsamestelling sowel as geestelike en fisiese prestasie te bereik.
Lees hierdie hele pamflet noukeurig deur voordat jy Lion's Mane Kapsules begin gebruik, aangesien dit belangrike inligting vir jou gesondheid bevat.
Lion's Mane Kapsules is beskikbaar sonder 'n dokters voorskrif om jou gesondheid te ondersteun en te handhaaf. Geruik steeds Lion's Mane Kapsules versigtig en verantwoordelik om die beste resultate te kry.
• Dit word voorgestel om hierdie inligting byderhand te hou ingeval jy weer daarna moet verwys.
• As jy enige verdere vrae het, vra jou gesondheidsorgverskaffer.
• Moenie Lion's Mane Kapsules met enige ander persoon deel nie.
• Indien enige van die newe-effekte ernstig word, of as jy enige newe-effekte opmerk wat nie in hierdie pamflet gelys word nie, raadpleeg asseblief jou gesondheidsorgverskaffer.
In hierdie pamflet:
1. Wat is Lion's Mane Kapsules en waarvoor gebruik word dit gebruik.
2. Wat jy moet weet voordat jy Lion's Mane Kapsules gebruik.
3. Hoe om Lion's Mane Kapsules te neem.
4. Moontlike newe-effekte.
5. Hoe om Lion's Mane-kapsules te bêre.
6. Inhoud van die pakkie en ander inligting.
1. WAT IS LION'S MANE KAPSULES EN WAARVOOR WORD DIT GEBRUIK
Lion's Mane Kapsules is 'n diëetaanvulling in kapsulevorm wat gebruik word om kognitiewe gesondheid en algehele welstand te ondersteun. Dit behoort tot die kategorie komplementêre medisyne.
2. WAT JY MOET WEET VOORDAT JY LION'S MANE KAPSULES GEBRUIK
Moenie Lion's Mane Kapsules gebruik as jy:
- Allergies is of as jy 'n bekende hipersensitiwiteit vir enige van die bestanddele het nie (sien 6. INHOUD VAN DIE VERPAKKING EN ANDER INLIGTING).
- Enige bekende sensitiwiteit vir sampioenprodukte het nie.
Waarskuwings en voorsorgmaatreëls:
- Praat met jou dokter of apteker voordat jy Lion's Mane Kapsules begin gebruik of as jy enige mediese toestande het.
- Hierdie produk is nie bedoel om enige siekte te diagnoseer, te behandel, te genees of te voorkom nie.
Kinders en adolessente:
Lion's Mane-kapsules word nie aanbeveel vir kinders onder 18 jaar sonder mediese advies nie. Lion's Mane-sampioen word oor die algemeen as veilig beskou, maar verdere studies is nodig om dit te ondersteun.
Ander medisyne en Lion's Mane-kapsules:
Vertel jou dokter of apteker as jy enige ander medisyne gebruik, onlangs geneem het of dalk neem, insluitend oor-toonbank medisyne en aanvullende medisyne. Neem asseblief kennis van die volgende:
1. Antistolmiddels en antiplatelet-middels: Lion's Mane sampioene kan antiplaatjie- of bloedverdunnings-eienskappe hê, wat moontlik die uitwerking van bloedverdunningsmedikasie soos warfarin, aspirien, klopidogrel en ander antikoagulante kan versterk. Hierdie interaksie kan die risiko van bloeding of kneusing verhoog.
2. Hipoglisemiese medikasie: Lion's Mane sampioene het bloedsuikerverlagende effekte. Daarom kan individue wat medikasie vir diabetes neem, soos insulien of orale hipoglisemiese middels (bv. metformien), 'n verbeterde bloedsuikerverlagende effek ervaar, wat die risiko van hipoglukemie verhoog.
3. Immunosuppressante: Sommige studies dui daarop dat Lion's Mane sampioene immunomodulerende effekte kan hê. Vir individue wat immuunonderdrukkende middels gebruik, soos dié wat gebruik word na orgaanoorplanting of vir outo-immuun siektes (bv. siklosporien, takrolimus), kan Lion's Mane moontlik inmeng met die beoogde immuunonderdrukking.
4. Antihipertensiewe middels: As gevolg van die potensiaal vir Lion's Mane om bloeddruk te verlaag, kan individue wat antihipertensiewe medikasie neem (bv. ACE-remmers, beta-blokkers) 'n bykomende bloeddrukverlagende effek ervaar, wat lei tot hipotensie.
5. Medikasie wat deur Sitochroom P450 Ensieme gemetaboliseer word: Lion's Mane kan die aktiwiteit van lewerensieme wat by geneesmiddelmetabolisme betrokke is, beïnvloed (veral CYP1A2, CYP2D6 en CYP3A4). Dit kan die vlakke en doeltreffendheid van verskeie medikasie wat deur hierdie ensieme gemetaboliseer word verander, soos sekere antidepressante, anti-epileptika en statiene.
Swangerskap en borsvoeding:
As jy swanger is of borsvoed, dink jy is dalk swanger, of beplan om 'n baba te hê, raadpleeg jou dokter of apteker voordat jy hierdie medisyne gebruik.
Bestuur en gebruik van masjiene:
Daar is geen bekende uitwerking van Lion's Mane sampioen op die vermoë om te bestuur of masjiene te gebruik nie.
3. HOE OM LION'S MANE KAPSULES TE GEBRUIK
Gebruik altyd hierdie diëetaanvulling soos aanbeveel deur jou dokter of apteker of presies soos beskryf word in hierdie pamflet. Gaan praat met jou dokter of apteker as jy nie seker is nie en stop gebruik dadelik indien newe-effekte ervaar word.
Dosis:
Volwassenes: Neem 4 kapsules in die oggend.
Metode van toediening:
Neem Lion's Mane Kapsules met water, met of sonder kos.
As jy te veel Lion's Mane Kapsules neem:
(Sien 4. MOONTLIKE NEWE-EFFEKTE)
In die geval van oordosis, kontak jou dokter of apteker. Indien nie een beskikbaar is nie, kontak die naaste hospitaal of gifsentrum.
As jy vergeet om Lion's Mane Kapsules te neem:
Neem dit sodra jy onthou. Moenie 'n dubbele dosis neem om 'n vergete dosis in te haal nie.
4. MOONTLIKE NEWE-EFFEKTE
Lion's Mane Kapsules kan newe-effekte hê. Nie alle newe-effekte is in hierdie pamflet ingesluit nie. Indien jou algemene gesondheid versleg of as jy enige nadelige effekte ervaar terwyl jy Lion's Mane Kapsules neem, raadpleeg asseblief jou gesondheidsorgverskaffer vir advies.
Algemene newe-effekte:
- Geen gerapporteer nie.
Ongewone newe-effekte:
- Gastro-intestinale ongemak (bv. naarheid, maagkrampe)
- Diarree
- Veluitslag of jeuk (allergiese reaksies)
- Asemhalingsprobleme (in seldsame gevalle, as gevolg van allergiese reaksies)
- Duiseligheid
- Bloedverdunningseffekte (verhoogde risiko van bloeding)
- Hipoglukemie (lae bloedsuiker)
Rapportering van newe-effekte:
As jy enige newe-effekte het, praat met jou dokter of apteker. Jy kan ook newe-effekte aan SAHPRA rapporteer via die ‘6.04 Adverse Drug Reaction Reporting Form’, aanlyn gevind onder SAHPRA se publikasies: https://www.sahpra.org.za/Publications/Index/8. Deur newe-effekte aan te meld, kan jy help om meer inligting te verskaf oor die veiligheid van Lion's Mane Kapsules.
5. HOE OM SOARING FREE LION'S MANE KAPSULES TE BÊRE
- HOU BUITE BEREIK VAN KINDERS.
- Stoor in 'n koel, droë plek onder 25°C en weg van direkte sonlig.
- Moenie hierdie medisyne gebruik na die vervaldatum wat op die verpakking aangedui word nie.
6. INHOUD VAN DIE PAK EN ANDER INLIGTING
Wat Lion's Mane Kapsules bevat:
- Die aktiewe bestanddeel is Lion's Mane sampioen (Hericium erinaceus) gedroogde poeier.
- Die groente kapsule is gemaak van Hidroxypropiel Methylcellulose (groente sellulose).
- Geen ander bestanddele word bygevoeg nie.
Hoe lyk Lion's Mane Kapsules en inhoud van die pakkie:
- Lion's Mane Kapsules word voorsien in 'n amberkleurige glasbottel en silwer metaaldeksel met 90 groentedoppe.
Vervaardiger:
- Soaring Free, 11 The Village, Capricorn Drive, Capricorn Park, Muizenberg, 7548
- Tel: 0861 000 976
- E-pos: info@superfoods.co.za
HIERDIE BLADJIE IS LAAS HERSIEN OP
September 2024
REGISTRASIE NOMMER
Sal by registrasie deur SAHPRA toegeken word.
TOEGANG TOT DIE OOREENSTEMMENDE PROFESSIONELE INLIGTING
Vir verdere inligting verwys na die Professionele Inligting van die produk wat by superfoods.co.za gevind kan word.
Hierdie ongeregistreerde medisyne is nie deur die SAHPRA vir sy kwaliteit, veiligheid en beoogde gebruik geëvalueer nie. Hierdie aanvulling is nie bedoel om enige siekte te diagnoseer, te behandel, te genees of te voorkom nie.