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.
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% 40mg
Magnesium oxide Magnesium (elemental) 28,9mg
Riboflavin Vitamin B2 25mg
Pyridoxine Vitamin B6 25mg
L-Carnitine tartrate Carnitine 12,5mg
Niacin Vitamin B3 5mg
D-alpha-tocopherol Vitamin E 5mg
Pantothenic acid Vitamin B5 4,2mg
Zinc AAC 20% Zinc (elemental) 1,5mg
Thiamine Vitamin B1 0,82mg
Methyl folate Folic acid 0,5mg
Cholecalciferol Vitamin D3 0,385mg
Retinol Vitamin A 0,29mg
Cyanocobalamin Vitamin B12 0,05mg
Biotin Vitamin H 0,026mg
In-active Ingredients: Magnesium Stearate, Starch Corn
SoyaIsoflavone: Possible allergen
2. 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.
3. BEFORE YOU TAKE/USE FEMOLENE ULTRA SR CAPSULES:
Do not take Femolene Ultra SR Capsules:
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.
4. HOW TO USE FEMOLENE ULTRA SR CAPSULES
Do not share medicine with any other person.
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.
5. 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:
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 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)
7. PRESENTATION OF FEMOLENE ULTRA SR CAPSULES
Dark pink capsules packed in a white bottle in an outer carton, presented in 30’s pack sizes.
8. IDENTIFICATION OF FEMOLENE ULTRA SR CAPSULES
Dark 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
March 2020
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.
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% 40mg
Magnesium oxide Magnesium (elemental) 28,9mg
Riboflavin Vitamin B2 25mg
Pyridoxine Vitamin B6 25mg
L-Carnitine tartrate Carnitine 12,5mg
Niacin Vitamin B3 5mg
D-alpha-tocopherol Vitamin E 5mg
Pantothenic acid Vitamin B5 4,2mg
Zinc AAC 20% Zinc (elemental) 1,5mg
Thiamine Vitamin B1 0,82mg
Methyl folate Folic acid 0,5mg
Cholecalciferol Vitamin D3 0,385mg
Retinol Vitamin A 0,29mg
Cyanocobalamin Vitamin B12 0,05mg
Biotin Vitamin H 0,026mg
2. 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.
3. 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)
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.
4. HOE OM FEMOLENE ULTRA SR KAPSULES TE GEBRUIK
Moenie medisyne met enige ander persoon deel nie.
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.
5. 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:
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. 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)
7. AANBIEDING VAN FEMOLENE ULTRA SR KAPSULES
Donkere pienk kapsules in ‘n wit bottel in ‘n buitenste karton verpak, aangebied in 30-pakkies.
8. IDENTIFIKASIE VAN FEMOLENE ULTRA SR KAPSULES
Donker pienk 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
Maart 2020