FEMOLENE ULTRA CAPSULES
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS:
Scheduled 0
PROPRIETY NAME AND DOSAGE FORM:
Femolene Ultra Capsules
Read this leaflet carefully because it contains important information for you
Femolene Ultra Capsules is available without a doctor’s prescription.
Keep this leaflet. You may need to read it again.
Do not share Femolene Ultra Capsules with any other person.
Ask your doctor, pharmacist, or healthcare provider if you need more information or advice.
1. WHAT FEMOLENE ULTRA CAPSULES CONTAINS:
Per one Capsule contains: Actives
Calcium Carbonate Calcium (elemental) 76,5mg
Ascorbic Acid Vitamin C 25mg
Isoflavones Soya Isoflavones 40% 20mg
Magnesium oxide Magnesium (elemental) 14,5mg
Riboflavin Vitamin B2 12,5mg
Pyridoxine Vitamin B6 12,5mg
L-Carnitine tartrate Carnitine 12,5mg
Niacin Vitamin B3 2,5mg
D-alpha-tocopherol Vitamin E 2,5mg
Pantothenic acid Vitamin B5 2,4mg
Zinc AAC 20% Zinc (elemental) 1,5mg
Thiamine Vitamin B1 0,4mg
Cholecalciferol Vitamin D3 0,197mg
Retinol Vitamin A 0,145mg
Cyanocobalamin Vitamin B12 0,025mg
Biotin Vitamin H 0,0134mg
In-active Ingredients: Magnesium Stearate, Starch Corn
SoyaIsoflavone: Possible allergen
2. WHAT FEMOLENE ULTRA CAPSULES IS USED FOR:
Femolene Ultra is a combination of soy isoflavones and multivitamins and minerals to help alleviate the symptoms of PMS and Menopause.
3. BEFORE YOU TAKE/USE FEMOLENE ULTRA CAPSULES:
Do not take Femolene Ultra Capsules:
If you are known to be hypersensitive (allergic) to (active ingredient) or any of the ingredients. (see; COMPOSITION)
Do not use if you currently have or previously had breast cancer and or breast tumors or if you are predisposed to breast cancer, as indicated by abnormal mammogram and/or biopsy, or family member with breast cancer. Thyroid disorders, bleeding disorders, surgery (anti-platelet effects), anemia, liver disorders, schizophrenia, angioplasty, Lieber’s disease, diabetes, hemochromatosis, hypercalcemia, renal osteodystrophy with hyperphosphatasemia, epilepsy, kidney stones, cardiac conditions. Always tell your health care provider if you are taking any other medicine. If you are pregnant or breastfeeding your baby, please consult your health care provider for advice before taking this medicine.
Pregnancy and breastfeeding:
Femolene Ultra Capsules is not recommended for pregnant and lactating mothers to use this medicine. Safety and efficacy on these conditions has not been investigated.
Important information about some of the ingredients of Femolene Ultra Capsules:
Soy Isoflavone: Possible allergen
Inactive: All inactive ingredient added on the formulation of Femolene Ultra Capsules are known to be well tolerated.
Taking/ Giving/ Using other medicines with Femolene Ultra Capsules:
Always tell your healthcare provider if you are taking any other complementary or traditional medicine before taking/using Femolene Ultra Capsules.
4. HOW TO USE FEMOLENE ULTRA CAPSULES
Do not share medicine with any other person.
PMS: Take one to two capsules daily for ten days before your period begins.
Menopause: Take one capsule twice a day.
Take the Capsule with sufficient quantity of liquid (e.g. one glass of water)
Always take Femolene Ultra Capsules exactly as per recommendation of the Package Insert or by your health care provider and if you are unsure.
In the event of over dose, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control center.
If you use more Femolene Ultra Capsules than you should:
Do not take more than recommended dose. (See Package Insert)
In the event of over dose, consult your doctor, pharmacist or healthcare provider. If neither is available, contact the nearest hospital or poison center.
If you forget to take / missed a dose of Femolene Ultra Capsules:
Do not take double dose to make up for forgotten individual doses.
5. POSSIBLE SIDE EFFECTS
There have not been cases of frequent or less frequent side effects reported when taking Femolene Ultra Capsules as yet.
Only in cases of over dose or hypersensitivity reaction you may experience the following side effects:
However you should consult with your healthcare provider before taking/using any dietary supplement ingredient.
Not all side effects are reported are included in this in this leaflet. Should your general health worsen or if you experience any untoward effects while taking this medicine, please consult your health care provider for advice.
6. STORAGE CONDITION
Store all medicines out of reach of children
Store in a cool, dry place below or at 25 0C.
Keep the container in the original packaging and in an outer carton.
Protect from light.
Do not store in a bathroom.
Do not use after expiry date stated on the label /carton and on the bottle.
Do not use Femolene Ultra Capsules if you notice any visible signs of deterioration. (e.g bad smell)
Return all unused medicine to your pharmacist/ supplier.
Do not dispose of unused medicines in drains or sewage systems. (e.g. drains or toilets)
7. PRESENTATION OF FEMOLENE ULTRA CAPSULES
Light pink capsules packed in a white bottle in an outer carton, presented in 60’s pack sizes.
8. IDENTIFICATION OF FEMOLENE ULTRA CAPSULES
Light pink capsules.
9. REGISTRATION NUMBER
Date of Registration of Medicines:
[Will be allocated by SAHPRA upon registration]
10. NAME AND ADDRESS OF REGISTRATION HOLDER
Kenza Health (Pty) Ltd Suite 177, Private BagX7, Northriding, 2162
11. DATE OF PUBLICATON
November 2020. Ver:003
FEMOLENE ULTRA KAPSULES
PASIËNTINLIGTINGSBLAADJIE
BYLAE STATUS:
Geskeduleer 0
EIENDOM NAAM EN DOSISVORM:
Femolene Ultra kapsules
Lees hierdie blaadjie sorgvuldig deur omdat dit belangrike inligting bevat
Femolene Ultra kapsules is beskikbaar sonder die voorskrif van ‘n dokter.Hou hierdie pamflet. Jy sal dit dalk weer moet lees.
Moet nie Femolene Ultra Kapsules met enige ander persoon deel nie. Vra jou dokter, apteker of gesondheidsorgverskaffer as jy meer inligting of advies nodig het.
1. WAT FEMOLENE ULTRA CAPSULES BEHOU:
Per een kapsule bevat: Aktiewe
Calcium Carbonate Calcium (elemental) 76,5mg
Ascorbic Acid Vitamin C 25mg
Isoflavones Soya Isoflavones 40% 20mg
Magnesium oxide Magnesium (elemental) 14,5mg
Riboflavin Vitamin B2 12,5mg
Pyridoxine Vitamin B6 12,5mg
L-Carnitine tartrate Carnitine 12,5mg
Niacin Vitamin B3 2,5mg
D-alpha-tocopherol Vitamin E 2,5mg
Pantothenic acid Vitamin B5 2,4mg
Zinc AAC 20% Zinc (elemental) 1,5mg
Thiamine Vitamin B1 0,4mg
Cholecalciferol Vitamin D3 0,197mg
Retinol Vitamin A 0,145mg
Cyanocobalamin Vitamin B12 0,025mg
Biotin Vitamin H 0,0134mg
0naktiewe bestanddele: Magnesiumstearaat, Styselkorn
Soja Isoflavone: Moontlike allergeen
2. WAT FEMOLENE ULTRA CAPSULES GEBRUIK IS VIR:
Femolene Ultra is ‘n kombinasie van soja isoflavone en multivitamiene en minerale om die simptome van PMS en Menopouse te verlig.
3. VOORDAT U NEEM / GEBRUIK FEMOLENE ULTRA CAPSULES GEE:
Moenie Femolene Ultra capsules neem nie:
As jy bekend is dat dit hipersensitief (allergies) is vir (aktiewe bestanddeel) of enige van die bestanddele. (sien; SAMESTELLING)
Moet nie gebruik as jy tans borskanker of borswasse het of voorheen gehad het nie, of as jy aan borskanker besig is, soos aangedui deur abnormale mammogram en / of biopsie, of familielid met borskanker.
Tiroïedversteurings, bloedingafwykings, chirurgie (bloedplaatjie-effekte), anemie,lewerafwykings, skisofrenie, antioplastie, Leber se siekte, diabetes, heamochromatosis, hiperkalsemie, renale osteodiestrofie met hipofosfemiemie, epilepsie, nierstene, kardiale toestande.
Vertel altyd jou gesondheidsorgverskaffer as jy enige ander medisyne gebruik. As u swanger is of borsvoed, raadpleeg u gesondheidsorgverskaffer vir advies voordat u hierdie medisyne gebruik.
Swangerskap en borsvoeding:
Femolene Ultra capsules word nie aanbeveel vir swanger en lakterende moeders om hierdie medisyne te gebruik nie. Veiligheid en doeltreffendheid onder hierdie toestande is nie ondersoek nie.
Belangrike inligting oor sommige van die bestanddele van Femolene Ultra capsules:
Soja-isoflavoon: Moontlike allergeen
Onaktief: Al die onaktiewe bestanddeel wat bygevoeg word op die formulering van Femolene Ultra capsules, is goed geduld.
Neem / Gee / Gebruik ander medisyne met Femolene Ultra capsules:
Vertel altyd jou gesondheidsorgverskaffer as jy enige ander aanvullende of tradisionele medisyne gebruik voordat jy Femolene Ultra capsules gebruik / gebruik.
4. HOE OM FEMOLENE ULTRA KAPSULES TE GEBRUIK
Moenie medisyne met enige ander persoon deel nie.
PMS: Neem een tot twee kapsules daagliks vir tien dae voor u periode begin.
Menopouse: Neem een kapsule twee keer per dag.
Neem die kapsules met voldoende hoeveelheid vloeistof (bv. Een glas water)
Neem altyd Femolene Ultra Capsules presies volgens die aanbeveling van die pakketinvoer of deur u gesondheidsorgverskaffer en indien u onseker is.
In geval van oordosering, raadpleeg u dokter of apteker. Indien nie beskikbaar is nie, kontak die naaste hospitaal of gifbeheersentrum.
As jy meer Femolene Ultra capsules gebruik as wat jy moet:
Moenie meer as die aanbevole dosis inneem nie. (Sien pakket invoegsel)
Raadpleeg u dokter, apteker of gesondheidsorgverskaffer in die geval van oordosering. As dit nie beskikbaar is nie, kontak die naaste hospitaal of gifsentrum.
As jy vergeet om ‘n dosis Femolene Ultra capsules te neem / gemis:
Moenie dubbel dosis neem om vergete individuele dosisse te vergemaklik nie.
5. MOONTLIKE NEWE EFFEKTE
Daar was nie gevalle van gereelde of minder gereelde newe-effekte wat gerapporteer word wanneer Femolene Ultra capsules nog geneem word nie.
Slegs in gevalle van oordosering of hipersensitiwiteitsreaksie kan u die volgende newe-effekte ervaar:
U moet egter met u gesondheidsorgverskaffer konsulteer voordat u ‘n voedingsaanvullingsbestanddeel gebruik.
Nie alle newe-effekte word aangemeld nie, word hierin in hierdie bylae ingesluit. Indien u algemene gesondheid vererger of indien u enige onnodige effekte ondervind wanneer u hierdie medisyne gebruik, raadpleeg u gesondheidsorgverskaffer vir advies.
6. BERGINGSAANWYSINGS
Bewaar alle medisyne buite bereik van kinders
Berg in ‘n koel, droë plek onder of by 25 ° C.
Hou die houer in die oorspronklike verpakking en in ‘n buitenste karton.
Beskerm teen lig.
Moenie in ‘n badkamer stoor nie.
Moet nie gebruik word na die vervaldatum wat op die etiket / karton en op die bottel aangedui word nie.
Moenie Femolene Ultra capsules gebruik as u enige sigbare tekens van agteruitgang sien nie. (bv. slegte reuk)
Stuur alle ongebruikte medisyne na u apteker / verskaffer terug.
Moet nie ongebruikte medisyne in riool- of rioolstelsels weggooi nie. (bv. dreineer of toilette)
7. AANBIEDING VAN FEMOLENE ULTRA KAPSULES
Ligte pienk kapsules wat in ‘n wit bottel in ‘n buitenste karton verpak is, word in 60-verpakkinggroottes aangebied.
8. IDENTIFIKASIE VAN FEMOLENE ULTRA CAPSULES
Ligte pink kapsules.
9. REGISTRASIENOMMER
Datum van registrasie van medisyne:
[Sal deur SAHPRA toegeken word by registrasie]
10. NAAM EN ADRES VAN REGISTRASIEHOUER
Kenza Health (Edms) Bpk Suite 177, Private BagX7, Northriding 2162
11. DATUM VAN PUBLIKASIE
November 2020. Ver:003