Norlevo patient info

Norlevo Pat Info_Norlevo patient Info 2012/04/18 12:11 PM Page 1 PASIËNT INLIGTINGSBROSJURE
Lees hierdie hele voubiljet noukeurig voordat u hierdie medisyne neem.
Hierdie medisyne is beskikbaar sonder ’n voorskrif vanaf u dokter, vir u om ’n toestand
te behandel.
Nieteenstaande moet u nog steeds NORLEVO versigtig gebruik om die beste resultate
te verkry.
• Hou hierdie voubiljet. U mag dit dalk weer moet lees.
• Vra u apteker indien u meer inligting of advies nodig het.
• U moet ’n dokter spreek indien u vermoed dat u swanger geraak het na die gebruik
Skeduleringstatus: S2
Die eiendomsnaam van die geneesmiddel:
Norlevo® Tablette
Wat hierdie medisyne bevat:
Die aktiewe bestanddeel is 0,75 mg levonorgestrel.
Die tablette bevat ook die volgende ander bestanddele: Laktose monohidraat,
mieliestysel, povidoon, anhidriese kolloide silika en magnesiumstearaat.
Waarvoor hierdie medisyne gebruik word:
NORLEVO is ’n orale kontraseptiewe middel vir gebruik in noodgevalle.
NORLEVO word aanbeveel vir die volgende gevalle:
Die voorkoming van swangerskap binne 72 uur na onbeskermde seksuele omgang, veral:
• Waar seksuele omgang plaasgevind het en u of u maat nie voorbehoedmiddels gebruik
• Indien u maat se kondoom gebreek het, afgegly het of onbehoorlik verwyder is, of • Waar u vrees dat u intra-uterine toestel dalk verwyder is;• Indien u vaginale diafragma dalk geskuif het of te vroeg verwyder is;• Indien u vrees dat die metode van koitus interruptus onsuksesvol was, of indien u seksuele omgang gehad het gedurende die periode dat u veronderstel was om vrugbaar te wees wanneer die ritme metode gebruik was; NORLEVO is bedoel om slegs tydens nood gebruik te word en is totaal ongeskik virgereelde kontrasepsie. Die betroubaarheid is nie so hoog soos die van die bekende “pil”,wat vir ten minste 21 dae van die menstruele siklus gebruik word nie.
Voordat die geneesmiddel geneem word:
Moenie NORLEVO gebruik:
• Indien u allergies is vir enige van die bestanddele nie;
• Indien daar ’n moontlikheid bestaan dat u reeds swanger kan wees, bv. indien
onbeskermde gemeenskap reeds plaasgevind het in dieselfde siklus of as die laastemaandstonde nie plaasgevind het nie; • In geval van abnormale vaginale bloeding;• In geval van erge lewerverswakking;• Indien u ’n geskiedenis van arteriële siekte het;• Indien u ’n ektopiese swangerskap gehad het.
Neem spesiale voorsorg met NORLEVO:
Nood kontrasepsie moet slegs uitsonderlik gebruik word, aangesien:
• dit nie swangerskap sal verhoed in alle gevalle nie;
• die geassosieerde hormonale oordosering nie aanbeveel word vir gereelde
• dit nie gereelde kontrasepsie kan vervang nie;• dit nie swangerskap kan onderbreek nie.
Die effektiwiteit van NORLEVO kan verlaag word indien u ander medikasies neem soosantikonvulsante wat fenobarbitone, fenotoien, primidien of karbamasepien bevat. Andermedisynes wat rifabutien, rifampisien, griseofulvien, ritonavier, Hypericum perforatum (Sint Janskruid) bevat kan ook die effektiwiteit van NORLEVO verlaag.
Swangerskap en laktasie:
NORLEVO word in borsmelk uitgeskei en borsvoeding moet nie plaasvind binne 6 ure na
die inname van NORLEVO nie.
Indien u swanger is moet hierdie medisyne nie gebruik word nie. Indien u borsvoed moet
u asseblief u geneesheer, apteker of ander gesondheidsorgwerker kontak vir advies.
Die neem van ander medisyne saam met NORLEVO:
Indien u ander medisyne op ’n gereelde basis neem, insluitende komplementêre of
tradisionele medisynes, kan die gebruik van NORLEVO saam met hierdie ander middels
ongewenste interaksies veroorsaak. Kontak asseblief u geneesheer, apteker of ander
gesondheidsorgwerker vir advies.
Hoe om hierdie middel te neem:
• Die behandeling genoodsaak die inname van twee tablette as ’n enkel dosis so gou moontlik,
verkieslik binne 12 ure en nie later as 72 ure (3 dae) na onbeskermde gemeenskap nie.
• NORLEVO kan enige tyd tydens die menstruele siklus gebruik word.
Hoe vroeër NORLEVO geneem word, hoe meer effektief is dit. Selfs baie hoë dosisse hormoon kan nie swangerskap verhoed as die bevrugte eiersel reeds in die uterus ingeplant is nie.
Alle verdere onbeskermde seksuele omgang moet verhoed word tot die volgendemaandstonde aanbreek, tot dan kan enige meganiese of chemiese metode (kondome,skuim, pessarium) van kontrasepsie gebruik word.
Moontlike newe-effekte:
Newe-effekte van NORLEVO mag die volgende insluit:
• Naarheid en braking; veranderinge in eetlus en gewig; vloeistofretensie; duiseligheid;
moegheid; hoofpyn; allergiese velreaksies en gevoeligheid van die borste.
• Veranderde menstruele siklus of ongereelde menstruele bloeding.
Die maandstonde mag vroeër of later as gewoonlik geskied. In elk geval moet u genees-heer besoek word 3 weke nadat NORLEVO geneem is, ongeag of bloeding plaasgevindhet of nie.
Berging van NORLEVO:
Moet nie u medikasie wat voorgeskryf is met ander mense deel nie.
Hou alle geneesmiddels buite die bereik en sig van kinders.
Die tablette moet nie geneem word indien dit na die vervaldatum op die houer is nie.
Stoor die tablette benede 25 °C en beskerm teen lig en vog.
Identifikasie van NORLEVO:
Wit, ronde, bikonvekse tablet met “NL” gegrafeer aan albei kante.
Aanbieding van NORLEVO:
2 Tablette is gepak in oranje plastiek foelie geseël op aluminium foelie stulpstroke.
1 Stulpstrook verpak in ’n gedrukte kartondosie.
Registrasienommer:
33/21.8.2/0471
Naam en besigheidsadres van die houer van die registrasiesertifikaat:
Actor Pharma (Edms) Bpk1
Eenheid 7, Royal Palm Sake Landgoed
Washingtonstraat 646
Halfway House
Midrand 1685
Datum van publikasie van hierdie pasiënt inligtingsbrosjure:
7 April 2006
® Norlevo is ’n geregistreerde handelsmerk van Actor Pharma1 Norlevo Pat Info_Norlevo patient Info 2012/04/18 12:11 PM Page 2 PATIENT INFORMATION LEAFLET
Read all of this leaflet carefully before you take this medicine.
This medicine is available without a doctor’s prescription, for you to treat a condition.
Nevertheless you still need to use NORLEVO carefully to get the best results from it.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• You must see a doctor if you think you still became pregnant after using this medicine.
Scheduling status: S2
The proprietary name of the medicine:
Norlevo® Tablet
What this medicine contains:
The active substance is 0,75 mg levonorgestrel.
The tablets also contain the following other ingredients: Lactose monohydrate, maize
starch, povidone, anhydrous colloidal silica, and magnesium stearate.
What this medicine is used for:
NORLEVO is an oral emergency contraceptive.
NORLEVO is recommended in the following situations:The prevention of pregnancy within 72 hours of unprotected sexual intercourse, particularly:• If you have had sexual intercourse where either you or your partner did not use a • If your partner’s condom has broken, slipped or been improperly removed, or if he has • If you fear that your intrauterine device has been expelled;• If your vaginal diaphragm or contraceptive cap has moved or if you have removed it • If you are afraid that the method of coitus interruptus has failed or if you have had sexual intercourse during the period when you are supposed to be fertile when usingthe rhythm method; NORLEVO is intended for emergencies only and is completely unsuitable for regular contraception. Its reliability is not as high as that of the familiar “pill”, which is taken forat least 21 days of the menstrual cycle.
Before taking this medicine:
Do not use NORLEVO:
• If you have an allergy to any of the ingredients.
• If there is a possibility that pregnancy already exists, e.g. if unprotected sexual
intercourse has already taken place in the same cycle or if the last menstrual periodfailed to occur.
• In the case of abnormal vaginal bleeding.
• In the case of severe hepatic impairment.
• If you have a history of arterial disease.
• If you have had an ectopic pregnancy. Take special care with NORLEVO:
Emergency contraception must be used exceptionally, since:
• it does not prevent a pregnancy in every instance;
• the associated hormonal overdosing is not advisable in the case of regular
• it cannot replace a regular contraception;• it cannot interrupt a pregnancy.
The efficacy of NORLEVO may be decreased if you are taking other medicines like anticonvulsants that contain phenobarbitones, phenytoin, primidene or carbamazepine.
Other medicines that contain rifabutin, rifampicin, griseofulvin, ritonavir, Hypericum perforatum (St John’s wort) can also decrease the efficacy of NORLEVO.
Pregnancy and lactation:
NORLEVO is secreted into breast milk and breast feeding should not occur within
6 hours of taking NORLEVO.
If you are pregnant, this medicine must not be used. If you are breast feeding your
baby, please consult your doctor, pharmacist or other healthcare professional for
advice.
Taking other medicines with NORLEVO:
If you are taking other medicines on a regular basis, including complementary or
traditional medicines, the use of NORLEVO with these medicines may cause undesirable
interactions. Please consult your doctor, pharmacist or other healthcare professional, for
advice.
How to take this medicine:
• The treatment necessitates the intake of two tablets as a single dose as soon as
possible, preferably within 12 hours and not later than 72 hours (3 days) after unprotected sexual intercourse. • NORLEVO can be taken at any time during the menstrual cycle.
The earlier NORLEVO is used, the more effective it is. Even extremely high doses of hormone can no longer prevent pregnancy once a fertilised ovum has become implantedin the uterus.
All further unprotected sexual intercourse must be avoided until the next menstrual period; until then only mechanical and/or chemical methods (condoms, foam, pessary)of contraception may be used.
Possible side effects:
The side effects of NORLEVO may include:
• Nausea and vomiting; changes in appetite or weight; fluid retention; dizziness, fatigue,
headache; allergic skin reactions; a feeling of breast tenderness.
• Altered menstrual cycles or irregular menstrual bleeding.
The menstrual period may occur earlier or later than usual. At all events, you should visit your doctor 3 weeks after taking NORLEVO regardless of whether bleeding has occurred or not.
Storing and disposing of NORLEVO:
Do not share medicines prescribed for you with others.
Keep all medicines out of reach and sight of children.
Do not take the tablets if they are past the expiry date on the box.
Do not store the tablets above 25 °C and protect them from moisture and light.
Identification of NORLEVO:
White, round, biconvex tablet with “NL” engraved on both faces.
Presentation of NORLEVO:
2 Tablets are packed in an orange plastic foil sealed on aluminium foil blister strips.
1 Blister strip with two tablets is packed in a printed cardboard box.
Registration number:
33/21.8.2/0471
Name and business address of the holder of the certificate of registration:
Actor Pharma (Pty) Ltd1
Unit 7, Royal Palm Business Estate
646 Washington Street
Halfway House
Midrand 1685
Date of publication of this patient information leaflet:
7 April 2006
® Norlevo is a registered trademark of Actor Pharma1 Company Reg No: 2008/008787/07

Source: http://www.actorpharma.co.za/documents/PATIENT%20INFORMATION%20LEAFLET.pdf