Femolene UTRA SR PIL

Femolene ULTRA SR Capsules

PATIENT INFORMATION LEAFLET

 

SCHEDULING STATUS:

Scheduled 0

         

PROPRIETY NAME AND DOSAGE FORM:

Femolene Ultra SR Capsules

 

Read this leaflet carefully because it contains important information for you

Femolene Ultra SR Capsules is available without a doctor’s prescription.

  • Keep this leaflet. You may need to read it again.
  • Do not share Femolene Ultra SR Capsules with any other person.
  • Ask your doctor, pharmacist or healthcare provider if you need more information or advice

 

  1. WHAT FEMOLENE ULTRA SR CAPSULES CONTAINS:

Per one Capsule contains: Active

Calcium Carbonate                         Calcium (elemental)                       153mg

Ascorbic Acid                                       Vitamin C                                                50mg

Isoflavones                                            Soya Isoflavones 40%                    100mg

Magnesium oxide                            Magnesium (elemental)              28,9mg

Riboflavin                                                Vitamin B2                                             25mg

Pyridoxine                                              Vitamin B6                                             25mg

Niacin                                                         Vitamin B3                                             5mg

D-alpha-tocopherol                        Vitamin E                                                5mg

Pantothenic acid                               Vitamin B5                                             4,2mg

Zinc AAC 20%                                       Zinc (elemental)                                3mg

Thiamine                                                 Vitamin B1                                             0,82mg

Methyl folate                                       Folic acid                                                 0,05mg

Cholecalciferol                                    Vitamin D3                                             385IU

Retinol                                                       Vitamin A                                                29IU

Cyanocobalamin                               Vitamin B12                                          0,05mg

Biotin                                                          Vitamin H                                                0,03mg

 

In-active Ingredients: Magnesium Stearate, Starch Corn  

SoyaIsoflavone: Possible allergen

 

  1. WHAT FEMOLENE ULTRA SR CAPSULES IS USED FOR:

Femolene Ultra SR  is a combination of soy isoflavones and multivitamins and minerals to help alleviate the symptoms of PMS and Menopause.

 

  1. BEFORE YOU TAKE/USE FEMOLENE ULTRA SR CAPSULES:

Do not take Femolene Ultra SR 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 SR 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 SR Capsules:

Soy Isoflavone: Possible allergen

Inactive: All inactive ingredient added on the formulation of Femolene Ultra SR Capsules are known to be well tolerated.

 

Taking/ Giving/ Using other medicines with Femolene Ultra SR Capsules:

Always tell your healthcare provider if you are taking any other complementary or traditional medicine before taking/using Femolene Ultra SR Capsules.

 

  1. HOW TO USE FEMOLENE ULTRA SR 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 a day.

Take the Capsule with sufficient quantity of liquid (e.g. one glass of water)

Always take Femolene Ultra SR Capsules exactly as per recommendation of the Package Insert or by your health care provider and if you are unsure.

In the event of overdose, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control center.

If you use more Femolene Ultra SR Capsules than you should:

Do not take more than recommended dose. (See Package Insert)

In the event of overdose, consult your doctor, pharmacist or healthcare provider. If neither is available, contact the nearest hospital or poison center.

If you forget to take / miss a dose of Femolene Ultra SR Capsules:

Do not take double dose to make up for forgotten individual doses.

 

  1. POSSIBLE SIDE EFFECTS

There have not been cases of frequent or less frequent side effects reported when taking Femolene Ultra SR Capsules.

Only in rare cases or hypersensitivity reaction you may experience the following side effects:

  • headaches,
  • nausea,
  • vomiting,
  • diarrhoea,
  • yellow-orange discoloration of the urine. 

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.

 

  1. 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 SR 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)

 

  1. PRESENTATION OF FEMOLENE ULTRA SR CAPSULES

Dark pink capsules packed in a white bottle in an outer carton, presented in 30’s pack sizes.       

 

  1. IDENTIFICATION OF FEMOLENE ULTRA SR CAPSULES

Dark pink capsules.

 

  1. REGISTRATION NUMBER

Date of Registration of Medicines:

[Will be allocated by SAHPRA upon registration]

 

  1. NAME AND ADDRESS OF REGISTRATION HOLDER

MyHealth365 (Pty)Ltd

P O Box 214, Northriding, , 2162

 

  1. DATE OF PUBLICATON

     March 2025 Ver 004

 

 

 

 

 

 

 

Femolene ULTRA SR kapsules

PASIËNTINLIGTINGSBLAADJIE

 

BYLAE STATUS:

Geskeduleer 0

          

EIENDOM NAAM EN DOSISVORM:

Femolene Ultra SR kapsules

 

Lees hierdie blaadjie sorgvuldig deur omdat dit belangrike inligting bevat

Femolene Ultra SR kapsules is beskikbaar sonder die voorskrif van ‘n dokter.

  • Hou hierdie pamflet. Jy sal dit dalk weer moet lees.
  • Moet nie Femolene Ultra SR kapsules met enige ander persoon deel nie.
  • Vra jou dokter, apteker of gesondheidsorgverskaffer as jy meer inligting of advies nodig het.

                                             

  1. WATTER FEMOLENE ULTRA SR KAPSULES INHOUD:

Per een Capsule bevat: Aktief

Calcium Carbonate                         Calcium (elemental)                       153mg

Ascorbic Acid                                       Vitamin C                                                50mg

Isoflavones                                            Soya Isoflavones 40%                    100mg

Magnesium oxide                            Magnesium (elemental)              28,9mg

Riboflavin                                                Vitamin B2                                             25mg

Pyridoxine                                              Vitamin B6                                             25mg

Niacin                                                         Vitamin B3                                             5mg

D-alpha-tocopherol                        Vitamin E                                                5mg

Pantothenic acid                               Vitamin B5                                             4,2mg

Zinc AAC 20%                                       Zinc (elemental)                                3mg

Thiamine                                                 Vitamin B1                                             0,82mg

Methyl folate                                       Folic acid                                                 0,05mg

Cholecalciferol                                    Vitamin D3                                             385IU

Retinol                                                       Vitamin A                                                29IU

Cyanocobalamin                               Vitamin B12                                          0,05mg

Biotin                                                          Vitamin H                                                0,03mg

 

0naktiewe bestanddele: Magnesiumstearaat, Styselkorn, Gelatienkapsule

Soja Isoflavone: Moontlike allergeen


  1. WAT FEMOLENE ULTRA SR KAPSULES WORD GEBRUIK VIR:

 Femolene Ultra SR is ‘n kombinasie van soja isoflavone en multivitamiene en minerale om die simptome van PMS en Menopouse te verlig.

 

  1. VOORDAT U FEMOLENE ULTRA SR KAPSULES GEBRUIK / GEBRUIK:

Moenie Femolene Ultra SR kapsules 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 SR kapsules 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 SR kapsules:

Soja-isoflavoon: Moontlike allergeen
Inaktief: Al die onaktiewe bestanddeel wat op die formulering van Femolene Ultra SR kapsules bygevoeg word, is bekend om goed verdra te word

Neem / Gee / Gebruik ander medisyne met Femolene Ultra SR kapsules: Vertel altyd aan u gesondheidsorgverskaffer as u enige ander aanvullende of tradisionele medisyne gebruik voordat u Femolene Ultra SR-kapsules neem / gebruik.

  1. HOE OM FEMOLENE ULTRA SR 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 per dag.

Neem die kapsule met voldoende hoeveelheid vloeistof (bv. Een glas water)

Neem altyd Femolene Ultra SR kapsules presies volgens aanbevelings 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 SR kapsules gebruik as wat jy moet:

Moenie meer as die aanbevole dosis inneem nie. (Sien pakketinvoegsel)

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 SR kapsules te neem / gemis:

Moenie dubbel dosis neem om vergete individuele dosisse te vergemaklik nie.

 

  1. MOONTLIKE BIJWERKINGE

Daar was nie gevalle van gereelde of minder gereelde newe-effekte wat gerapporteer word wanneer Femolene Ultra SR kapsules geneem word nie.

Slegs in skaars gevalle of hipersensitiwiteitsreaksie kan u die volgende newe-effekte ervaar:

  • hoofpyn,
  • naarheid,
  • braking,
  • diarree,
  • geel-oranje verkleuring van die urine.

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.

 

  1. STORAGE VOORWAARDE

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 SR kapsules 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 verkoop nie. (bv. dreineer of toilette)

 

  1. AANBIEDING VAN FEMOLENE ULTRA SR KAPSULES

Donkere pienk kapsules in ‘n wit bottel in ‘n buitenste karton verpak, aangebied in 30-pakkies.

 

  1. IDENTIFIKASIE VAN FEMOLENE ULTRA SR KAPSULES

Donker pienk kapsules.

 

  1. REGISTRASIENOMMER

Datum van registrasie van medisyne:

[Sal deur SAHPRA toegeken word by registrasie]

 

  1. NAAM EN ADRES VAN REGISTRASIEHOUER

MyHealth365 (Edms) Bpk

P O Box 214, Northriding, 2162

 

  1. DATUM VAN PUBLIKASIE

Maart 2025, Ver 004