FEMOLENE VAGINAL SPRAY
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS:
Scheduled 0
PROPRIETY NAME AND DOSAGE FORM:
Femolene Vaginal Spray
Read this leaflet carefully because it contains important information for you
Femolene Vaginal Spray is available without a doctor’s prescription.
1. WHAT FEMOLENE VAGINAL SPRAY CONTAINS:
Each ml contains 300 million CFU (colony forming units)
2. WHAT FEMOLENE VAGINAL SPRAY IS USED FOR:
Vaginal dryness, vaginal thrush, urinary tract infection (UTI) and bacterial vaginosis.
3. BEFORE YOU TAKE/ USE FEMOLENE LUBRICATING VAGINAL SPRAY:
Do not take Femolene Vaginal Spray:
If you are known to be hypersensitive (allergic) to (active ingredient) or any of the ingredients. (see; COMPOSITION)
Always tell your health care provider if you are taking any other medicine. If you are pregnant or breastfeeding consult your health care provider for advice before taking this medicine.
PREGNANCY AND LACTATION:
Reduce the risk of bacterial vaginosis during pregnancy.
Important information about some of the ingredients of Femolene Vaginal Spray:
Inactive: All inactive ingredients added to the formulation of Femolene Lubricating Vaginal Spray are known to be well tolerated.
Taking/ Giving/ Using other medicines with Femolene Vaginal Spray:
Always tell your healthcare provider if you are taking any other complementary or traditional medicine before taking/using Femolene Vaginal Spray.
4. HOW TO USE FEMOLENE VAGINAL SPRAY
Do not share medicine with any other person.
Always take Femolene Vaginal Spray 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 Vaginal Spray 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/ miss a dose of Femolene Vaginal Spray:
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 Vaginal Spray to date.
However, you should consult with your healthcare provider before taking/ using any dietary supplement ingredient.
Not all side effects reported are included 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 25C.
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 Vaginal Spray 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 VAGINAL SPRAY
A 25-ml amber glass bottle with a metered spray insert, containing approximately 80 sprays respectively.
8. IDENTIFICATION OF FEMOLENE VAGINAL SPRAY
An oily liquid with suspended material having an acidic smell.
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 Bag X7, Northriding 2162
11. DATE OF PUBLICATON
October 2019
FEMOLENE VAGINAL SPRAY
PASIËNTINLIGTINGSBLAADJIE
BYLAE STATUS:
Geskeduleer 0
EIENDOM NAAM EN DOSISVORM:
Femolene Vaginal Spray
Lees hierdie blaadjie sorgvuldig deur omdat dit belangrike inligting bevat
Femolene Vaginal Spray is beskikbaar sonder die voorskrif van ‘n dokter.
1. WAT FEMOLENE ULTRAKAPSULES BEHOU:
Per een kapsule bevat: Aktiewe
2. WAT FEMOLENE VAGINALE SPRAY WORD VOOR:
Vaginale droogheid, vaginale sproei, urienweginfeksie (UTI) en bakteriese vaginose.
3. VOORDAT U FEMOLENE VAGINALE SPRUIS GEBRUIK / GEBRUIK:
Moenie Femolene Vaginale Spuit neem indien :
Jy bewus is daarvan dat jy 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 Lubricating Vaginal Spray word nie aanbeveel vir swanger en lakterende moeders vir gebruik nie. Veiligheid en doeltreffendheid onder hierdie toestande is nie ondersoek nie.
Belangrike inligting oor sommige van die bestanddele van Femolene Vaginal Spray:
Soja-isoflavoon: Moontlike allergeen (TAKE OUT?)
Onaktief: Al die onaktiewe bestanddeel wat bygevoeg word op die formulering van Femolene Lubricating Vaginal Spray, word goed verdra.
Neem / Gee / Gebruik ander medisyne met Femolene Vaginal Spray:
Vertel altyd jou gesondheidsorgverskaffer as jy enige ander aanvullende of tradisionele medisyne gebruik voordat jy Femolene Lubricating Vaginal Spray gebruik / gebruik.
4. HOE OM FEMOLENE VAGINALE SPRAY TE GEBRUIK
Moenie medisyne met enige ander persoon deel nie.
Raadpleeg u dokter of apteker in geval van oordosis. Indien nie beskikbaar is nie, kontak die naaste hospitaal of gifbeheersentrum.
As jy meer Femolene Vaginale Spray gebruik as wat jy moet:
Moenie meer as die aanbevole dosis inneem nie. (Sien pakketinvoegsel)
In geval van oor dosis, raadpleeg u dokter, apteker of gesondheidsorgverskaffer. As dit nie beskikbaar is nie, kontak die naaste hospitaal of gifsentrum.
As jy vergeet om ‘n dosis Femolene Vaginale Spuit 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 Vaginal Spray nog geneem word nie.
U moet egter met u gesondheidsorgverskaffer konsulteer voordat u ‘n voedingsaanvullingsbestanddeel gebruik.
Nie alle newe-effekte word aangemeld nie, slegs newe – effekte wat wel aangemeld was word 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 Lubricating Vaginal Spray 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 gooi nie. (bv. dreineer of toilette)
7. AANBIEDING VAN FEMOLENE VAGINALE SPRAY
‘n 25 ml amberglas bottel met ‘n gemeterde spuitbout, wat onderskeidelik ongeveer 80 bespuitings bevat.
8. IDENTIFIKASIE VAN FEMOLENE LUBRICATING VAGINAL SPRAY
‘n Olierige vloeistof met geskorsde materiaal met ‘n suur reuk.
9. REGISTRASIENOMMER
Datum van registrasie van medisyne:
[Sal deur SAHPRAtoegeken word by registrasie]
10. NAAM EN ADRES VAN REGISTRASIEHOUER
Kenza Health (Edms) Bpk Suite 177, Private BagX7, Northriding 2162
11. DATUM VAN PUBLIKASIE
Oktober 2019