AROMATHERAPYThis medicine has not been evaluated by the Medicines Control Council. This medicine is not intended to diagnose, treat, cure or prevent any disease.

SCHEDULING STATUSSchedule 0

PROPRIETARY NAME AND DOSAGE FORMkhloris® Relief OIL

Read all of this leaflet carefully because it contains important information for you.khloris® Relief OIL is available without a doctor’s prescription, for you to treat a mild illness. Nevertheless, you still need to use khloris® Relief OIL carefully to get the best results from it.

• Keep this leaflet. You may need to read it again.

• Do not share khloris® Relief OIL with any other person.

• Ask you pharmacist if you need more information or advice.

• You must see a doctor if your symptoms worsen or do not improve after 7 days.

1. WHAT khloris® Relief OIL CONTAINSThe active substances are:

Each 50 ml contains:

Methyl salicylate (oil of wintergreen) 6,29 g

Eucalyptus oil 3,71 g

Menthol crystals 3,22 g

Lavender oil 1,29 g

The other ingredients are mineral oil.

2. WHAT khloris® Relief OIL IS USED FORkhloris® Relief OIL alleviates symptoms associated with:

Muscle stiffness

Sports injuries

Inflammation.

3. BEFORE YOU USE khloris® Relief OIL

Do not use khloris® Relief OIL:

If you are hypersensitive (allergic) to Methyl salicylate (oil of wintergreen), eucalyptus oil, menthol crystals, lavender oil or any of the other ingredients of khloris® Relief OIL (see WHAT khloris® Relief OIL CONTAINS).

Take special care with khloris® Relief OIL:

• If you are applying it to broken skin, you may experience a burning sensation.

• If you use khloris® Relief OIL for a long period of time you may experience salicylate toxicity (nausea, vomiting, dizziness, loss of vision, ringing in your ears, confusion, difficulty breathing, drowsiness, headache, fever or seizures). Contact your doctor immediately.

Pregnancy and breastfeeding:If you are pregnant or breastfeeding your baby, please consult your doctor, pharmacist or other healthcare professional for advice before using khloris® Relief OIL.Do not use khloris® Relief OIL if you are pregnant or breastfeeding

Taking other medicines with khloris® Relief OIL: Always tell your healthcare professional if you are taking any other medicine. (This includes complementary or traditional medicines.)Tell your doctor or pharmacist if you are currently using:

• Any other topical application (used to treat a skin condition or allergy).

• Warfarin (used to prevent your blood from clotting).

4. HOW TO USE khloris® Relief OIL

Do not share medicines prescribed for you with any other person.

Always use khloris® Relief OIL exactly as instructed. You should check with your doctor or pharmacist if you are unsure.

khloris® Relief OIL is for external use only.

The healing and soothing properties of the combined oils in khloris® Relief OIL are activated by heat. Therefore, it is recommended to gently massage a tiny amount of the khloris® Relief OIL onto the affected area. Massage well for proper penetration. Apply 1 – 3 times daily.

Consult a healthcare practitioner if your symptoms persist for more than 7 days.

Wash your hands thoroughly after use.

Avoid contact with your eyes. If khloris® Relief OIL comes into contact with your eyes, rinse immediately with water and seek medical assistance if the irritation persists.

If you have the impression that the effect of khloris® Relief OIL is too strong or too weak, tell your doctor or pharmacist.

If you use more khloris® Relief OIL than you should:In the event of an overdose or if you or your child accidentally ingests khloris® Relief OIL , consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

Take this leaflet and the remaining khloris® Relief OIL with you so the doctor will know what you have used/taken.

5. POSSIBLE SIDE EFFECTSkhloris® Relief OIL can have side effects. Not all side effects reported for khloris® Relief OIL are included in this leaflet. Should your general health worsen or if you experience any untoward effects while using khloris® Relief OIL, please consult your doctor, pharmacist or other healthcare professional for advice.

If any of the following happens, stop using khloris® Relief OIL and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swelling of your hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing.

• Rash or itching.

• Fainting.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to khloris® Relief OIL. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

Frequency unknown:

Salicylate toxicity (nausea, vomiting, dizziness, loss of vision, ringing in your ears, confusion, difficulty breathing, drowsiness, headache, fever or seizures).These are all serious side effects. You may need urgent medical attention.

Tell your doctor as soon as possible if you notice any of the following:

Less frequent

Inflammation (redness) or irritation of your skin in the area of application.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

6. STORING AND DISPOSING OF khloris® Relief OIL

Store at or below 25 °C.

STORE ALL MEDICINES OUT OF REACH OF CHILDREN.

Do not use after the expiry date printed on the carton.

Return all unused medicine to your pharmacist.

Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).

7. PRESENTATION OF khloris® Relief OIL

Plastic Bottle with a screw on lid, packed in an outer carton.

Pack size: 50 ml.

8. IDENTIFICATION OF khloris® Relief OIL

Oil, colourless.

9. REGISTRATION NUMBERTo be allocated by Council upon registration.

10.NAME AND ADDRESS OF REGISTRATION HOLDERkhloris® Healthcare SolutionsPO Box 41214Musgrave RoadDurban 4062South Africa

11.DATE OF PUBLICATIONTo be allocated by Council upon registration.

AROMATERAPIEHierdie medisyne is nie deur die Medisynebeheerraad geëvalueer nie. Hierdie medisyne is nie bedoel om enige siekte te diagnoseer, behandel, genees of te voorkom nie.

SKEDULERINGSTATUSSkedule 0

HANDELSNAAM EN DOSEERVORMkhloris® Relief OLIE

Lees die hele inligtingsblad noukeurig want dit bevat inligting wat belangrik is vir u.khloris® Relief OLIE is beskikbaar sonder ‘n dokter se voorskrif, sodat u ‘n ligte aandoening kan behandel. U moet khloris® Relief OLIE nogtans met oorleg gebruik om die beste resultate te kry. • Hou hierdie inligtingsblad. Dit mag nodig wees dat u dit later weer lees.

• Moenie khloris® Relief OLIE met enigiemand anders deel nie.

• Vra u apteker indien u meer inligting of advies benodig.

• U moet u dokter spreek indien u simptome vererger of na 7 dae nie verbeter het nie.

1. WAT khloris® Relief OLIE BEVATDie aktiewe bestanddele is:

Elke 50 ml bevat:

Metielsalisilaat (wintergroenolie) 6,29 g

Eucalyptusolie 3,71 g

Mentolkristalle 3,22 g

Laventelolie 1,29 g

Die ander bestanddele is mineraal olie.

2. WAARVOOR khloris® Relief OLIE GEBRUIK WORDkhloris® Relief OLIE verlig simptome geassosieer met:

Spierstyfheid

Sportbeserings

Inflammasie.

3. VOORDAT U khloris® Relief OLIE GEBRUIKMoenie khloris® Relief OLIE gebruik nie:

Indien u hipersensitief (allergies) is vir Metielsalisilaat (wintergroenolie), eucalyptusolie, mentolkristalle, laventelolie of vir enige van die ander bestanddele van khloris® Relief OLIE (kyk WAT khloris® Relief OLIE BEVAT).

Neem spesiale sorg met khloris® Relief OLIE:

• U mag ‘n brandgevoel ervaar indien u dit aan stukkende vel aanwend.

• Indien u khloris® Relief OLIE vir ‘n lang periode gebruik, mag u salisilaattoksisiteit ervaar (naarheid, braking, duiseligheid, sigverlies, gesuis in die ore, verwarring, moeilike asemhaling, lomerigheid, hoofpyn, koors of toevalle). Kontak u dokter onmiddellik.

Swangerskap en borsvoeding:Indien u swanger is of u baba borsvoed, raadpleeg asseblief eers u dokter, apteker of ander gesondheidsorgdeskundige voordat u khloris® Relief OLIE gebruik.Moenie khloris® Relief OLIE gebruik indien u swanger is of u baba borsvoed nie.

Die neem van ander medisynes saam met khloris® Relief OLIE: Sê altyd vir u gesondheidsorgdeskundige indien u enige ander medisyne neem. (Dit sluit aanvullende of tradisionele medisynes in.)Sê vir u dokter of apteker indien u tans enige van die volgende gebruik:

• Enige ander middel wat topikaal aangewend word (gebruik om ‘n veltoestand of allergie te behandel).

• Warfarien (gebruik om te keer dat u bloed stolsels maak)

4. HOE OM khloris® Relief OLIE TE GEBRUIKMoenie medisyne wat vir u voorgeskryf is, met enigiemand anders deel nie.

Gebruik khloris® Relief OLIE altyd presies soos wat vir u aangedui is. Kontroleer met u dokter of apteker indien u onseker is.

khloris® Relief OLIE is slegs vir uitwendige gebruik.

Die genesende en strelende eienskappe van die oliekombi-nasie in khloris® Relief OLIE word deur hitte geaktiveer. Masseer ‘n klein hoeveelheid van die khloris® Relief OLIE liggies aan die aangetaste dele.

Masseer goed om deeglike penetrasie te verseker. Wend 1 – 3 keer daagliks aan.

Raadpleeg ‘n gesondheidsorgpraktisyn indien u simptome vir langer as 7 dae voortduur.

Was u hande deeglik na aanwending.

Vermy kontak met u oë. Indien khloris® Relief OLIE in u oë kom, spoel onmiddellik uit met water en verkry mediese bystand indien die irritasie voortduur.

Indien u die indruk kry dat die uitwerking van khloris® Relief OLIE te sterk of te swak is, sê dit vir u dokter of apteker.

Indien u meer khloris® Relief OLIE gebruik as wat u moet:In geval van oordosering of indien u of u kind khloris® Relief OLIE per ongeluk mondeliks ingeneem het, raadpleeg u dokter of apteker. Indien nie een van hulle beskikbaar is nie, kontak die naaste hospitaal of gifsentrum.

Neem hierdie inligtingsblad en die oorblywende khloris® Relief OLIE saam sodat die dokter kan sien wat u gebruik/ingeneem het.

5. MOONTLIKE NEWE-EFFEKTEkhloris® Relief OLIE kan newe-effekte hê.Nie alle newe-effekte wat vir khloris® Relief OLIE aangemeld is, word in hierdie inligtingsblad ingesluit nie.Indien u algemene gesondheid agteruitgaan of indien u enige ongunstige effekte ervaar terwyl khloris® Relief OLIE gebruik word, raadpleeg asseblief u dokter, apteker of ander gesondheidsorgdeskundige.

Indien enige van die volgende gebeur, hou op om khloris® Relief OLIE te gebruik en sê onmiddellik vir u dokter of gaan na die ongevalle-afdeling by u naaste hospitaal:

• Swelling van u hande, voete, enkels, gesig, lippe, mond of keel, wat probleme met sluk of asemhaling kan veroorsaak. • Uitslag of gejeuk.

• Floutes.

Hierdie is almal baie ernstige newe-effekte. Indien u dit ondervind, mag u ‘n ernstige allergiese reaksie op khloris® Relief OLIE gehad het. U mag dringende mediese sorg of hospitalisasie benodig.

Sê onmiddellik vir u dokter of gaan na die ongevalle-afdeling by u naaste hospitaal indien u enige van die volgende opmerk:

Frekwensie onbekend:

Salisilaattoksisiteit (naarheid, braking, duiseligheid, sigverlies, gesuis in die ore, verwarring, moeilike asemhaling, lomerigheid, hoofpyn, koors of toevalle).Hierdie is almal ernstige newe-effekte. U mag dringende mediese sorg nodig hê.

Sê so gou as moontlik vir u dokter indien u enige van die volgende opmerk:

Minder dikwels

Inflammasie (rooiheid) of irritasie van u vel in die area waar dit aangewend is.

Indien u enige ander newe-effekte opmerk wat nie in hierdie inligtingsblad genoem is nie, lig asseblief u dokter of apteker daarvan in.

6. BERGING EN WEGDOENING VAN khloris® Relief OLIE

Bêre by of onder 25 °C.

BÊRE ALLE MEDISYNES BUITE BEREIK VAN KINDERS.

Moenie gebruik ná die vervaldatum wat op die karton gedruk is nie.

Neem alle ongebruikte medisyne terug na u apteker.

Moenie ongebruikte medisyne in dreine en rioolstelsels (bv. toilette) weggooi nie.

7. AANBIEDING VAN khloris® Relief OLIE

Plastiek bottel met ‘n aanskroefdeksel, verpak in ‘n buitenste karton.

Verpakkingsgrootte: 50 ml.

8. IDENTIFIKASIE VAN khloris® Relief OLIE

Olie, kleurloos.

9. REGISTRASIENOMMERSal deur die Raad toegeken word met registrasie.

10.NAAM EN ADRES VAN DIE REGISTRASIEHOUERkhloris® Healthcare SolutionsPosbus 41214MusgravewegDurban 4062South Africa

11.DATUM VAN PUBLIKASIESal deur die Raad toegeken word met registrasie.

PATIENT INFORMATION LEAFLET FOR khloris® Relief OIL

PASIËNTINLIGTINGSBLAD VIR khloris® Relief OLIE

OIL

SO

AROMATHERAPYThis medicine has not been evaluated by the Medicines Control Council. This medicine is not intended to diagnose, treat, cure or prevent any disease.

SCHEDULING STATUSS0

PROPRIETARY NAME AND DOSAGE FORMkhloris® Relief OIL

COMPOSITION

Active ingredients:

Each 50 ml contains:

Methyl salicylate (oil of wintergreen) 6,29 g

Eucalyptus oil 3,71 g

Menthol crystals 3,22 g

Lavender oil 1,29 g

Inactive ingredients:

Mineral oil.

PHARMACOLOGICAL CLASSIFICATION

D 17.3 Medicines acting on muscular system, Others

PHARMACOLOGICAL ACTION

Methyl salicylate (oil of wintergreen) It has antipyretic, anti-inflammatory and analgesic properties, which may be attributed to its counterirritant effect. Eucalyptus oil has an active agent indicated for relieving certain cold symptoms and/or certain muscular sprains and cramps, it is antimicrobial properties. The topical application of menthol shows a direct inhibitory effect on the sensitised pain receptors. It may also act centrally to alter pain perception. Lavender oil contains multiple constituents, including cineole, linalool, linalyl acetate and carophyllene epoxide. It induces relaxation and sedation.

INDICATIONSkhloris® Relief OIL alleviates symptoms associated with:

Muscle stiffness

Sports injuries

Inflammation.

CONTRAINDICATIONS

Hypersensitivity to Methyl salicylate (oil of wintergreen), eucalyptus oil, menthol crystals, lavender oil or to any of the inactive ingredients of khloris® Relief OIL (see COMPOSITION).

WARNINGS AND SPECIAL PRECAUTIONS

A stinging or burning sensation may be felt when applied to broken skin. The prolonged topical application of Methyl salicylate (oil of wintergreen), as in khloris® Relief OIL , can increase the systemic absorption of methyl salisylate which may increase the risk of salicylate toxicity and caution is advised (see INTERACTIONS).

INTERACTIONS

Do not use in combination with other topical applications.The prolonged topical application of wintergreen, as in khloris® Relief OIL, can increase the systemic absorption of methyl salicylate which may increase the risk of salicylate toxicity and caution is advised (see WARNINGS AND SPECIAL PRECAUTIONS). It may also increase the international normalised ratio (INR) when used concomitantly with warfarin or other blood thinning medication, which may increase the risk of bleeding and caution is advised.

PREGNANCY AND LACTATION

Safety in pregnancy and lactation has not been established. Do not take khloris® Relief OIL during pregnancy or lactation.

DOSAGE AND DIRECTIONS FOR USE

For external use only. The healing and soothing properties of the combined oils in khloris® Relief OIL are activated by heat. Therefore, it is recommended to gently massage a tiny amount of the khloris® Relief OIL onto the affected area.

Massage well for proper penetration. Apply 1 – 3 times daily. Consult a healthcare practitioner if symptoms persist for longer than 7 days. Wash hands thoroughly after use. Avoid contact with eyes. If khloris® Relief OIL comes into contact with the eyes, rinse immediately with water and seek medical assistance if the irritation persists.

SIDE EFFECTSSkin and subcutaneous tissue disorders:

Less frequent: Contact dermatitis, skin irritation

Injury and poisoning:

Frequency unknown: Salicylate intoxication.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT

See SIDE EFFECTS.

In the event of overdosage, treatment should be symptomatic and supportive.

IDENTIFICATION

Oil, colourless.

PRESENTATION

Plastic Bottle with a screw on lid, packed in an outer carton.

Pack size: 50 ml.

STORAGE INSTRUCTIONS

Store at or below 25 °C.

KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER

To be allocated by Council upon registration.

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION

khloris® Healthcare SolutionsPO Box 41214Musgrave RoadDurban 4062South Africa

DATE OF PUBLICATION OF THE PACKAGE INSERT

To be allocated by Council upon registration.

AROMATERAPIEHierdie medisyne is nie deur die Medisynebeheerraad geëvalueer nie. Hierdie medisyne is nie bedoel om enige siekte te diagnoseer, behandel, genees of te voorkom nie.

SKEDULERINGSTATUSS0

HANDELSNAAM EN DOSEERVORMkhloris® Relief OLIE

SAMESTELLING

Aktiewe bestanddele:

Elke 50 ml bevat:

Metielsalisilaat (wintergroenolie) 6,29 g

Eucalyptusolie 3,71 g

Mentolkristalle 3,22 g

Laventelolie 1,29 g

Onaktiewe bestanddele:

Mineraal olie.

FARMAKOLOGIESE KLASSIFIKASIE

D 17.3 Medisynes wat inwerk op die spierstelsel, Ander

FARMAKOLOGIESE WERKING

Metielsalisilaat (wintergroenolie) dit het koorswerende, anti-inflammatoriese en pynstillende eienskappe, wat toegeskryf kan word aan die kontra-irritasiewerking daarvan. Eucalyptusolie het pynstillende, anestetiese en antipruritiese eienskappe. Die topikale aanwending van mentol toon ‘n direkte onderdrukkende effek op die gesensitiseerde pynreseptore. Dit mag ook sentraal werk om pynpersepsie te wysig. Laventelolie bevat verskeie bestanddele, insluitend sineool, linalool, linalielasetaat en karofilleenepoksied. Dit induseer ontspanning en sedasie.

INDIKASIESkhloris® Relief OLIE verlig simptome geassosieer met:

Spierstyfheid

Sportbeserings

Inflammasie.

KONTRAINDIKASIESHipersensitiwiteit vir Metielsalisilaat (wintergroenolie), eucalyptusolie, mentolkristalle, laventelolie of vir enige van die onaktiewe bestanddele van khloris® Relief OLIE (kyk SAMESTELLING).

WAARSKUWINGS EN SPESIALE VOORSORGMAATREËLS'n Stekende of brandende sensasie kan gevoel word wanneer dit op die gebreekte vel toegedien word. Die langdurige topikale toediening van Metielsalisilaat (Wintergreenolie), soos in khloris® Relief OLIE, kan die sistemiese absorpsie van metielsalisilaat verhoog wat die risiko van salisilaat-toksisiteit verhoog en versigtigheid word aangeraai. (kyk INTERAKSIES).

INTERAKSIESMoenie in kombinasie met ander topikale aanwendings gebruik nie. Verlengde topikale aanwending van wintergroen, soos in khloris® Relief OLIE, kan die sistemiese absorpsie van metielsalisilaat verhoog, wat die risiko van salisilaattoksisiteit kan laat toeneem en versigtigheid word aangeraai (kyk WAARSKUWINGS EN SPESIALE VOORSORGMAATREËLS). Dit kan ook die internasionale normaliseerde verhouding (INR) verhoog wanneer dit terselfdertyd as warfarien of ander bloedverdunningsmedikasie gebruik word, wat die risiko vir bloeding kan verhoog en versigtigheid word aanbeveel.

SWANGERSKAP EN BORSVOEDINGVeiligheid tydens swangerskap en borsvoeding is nie bepaal nie. khloris® Relief OLIE moenie tydens swangerskap of borsvoeding gebruik word nie.

DOSIS EN GEBRUIKSAANWYSINGS

Slegs vir uitwendige gebruik.

Die genesende en strelende eienskappe van die gekombi-neerde olies in khloris® Relief OLIE word deur hitte geaktiveer. Dit word dus aanbeveel dat ‘n klein hoeveelheid van die khloris® Relief OLIE liggies aan die geaffekteerde area gemasseer word.

Masseer goed vir deeglike penetrasie. Wend 1 – 3 keer daagliks aan. Konsulteer ‘n gesondheidsorgpraktisyn indien simptome vir langer as 7 dae volhou.

Was die hande deeglik na gebruik. Vermy kontak met die oë. Indien khloris® Relief OLIE in kontak met die oë kom, spoel onmiddellik met water uit en verkry mediese bystand indien die irritasie voortduur.

NEWE-EFFEKTEVel- en subkutaneweefselversteurings:

Minder dikwels: Kontakdermatitis, velirritasie

Besering en vergiftiging:

Frekwensie onbekend: Salisilaatvergiftiging.

BEKENDE SIMPTOME VAN OORDOSERING EN BESONDERHEDE VIR DIE BEHANDELING

Kyk NEWE-EFFEKTE.

In die geval van oordosering moet behandeling simptomaties en ondersteunend wees.

IDENTIFIKASIE

Olie, kleurloos.

AANBIEDING

Plastiek bottel met ‘n aanskroefdeksel, verpak in ‘n buitenste karton.Verpakkingsgrootte: 50 ml.

BEWARINGSINSTRUKSIES

Bêre by of onder 25 °C.

HOU BUITE BEREIK VAN KINDERS.

REGISTRASIENOMMER

Sal deur die Raad toegeken word met registrasie.

NAAM EN BESIGHEIDSADRES VAN DIE HOUER VAN DIE REGISTRASIESERTIFIKAAT

khloris® Healthcare SolutionsPO Box 41214Musgrave RoadDurban 4062South Africa

DATUM VAN PUBLIKASIE VAN DIE VOUBILJET

Sal deur die Raad toegeken word met registrasie.

PACKAGE INSERT FOR khloris® Relief OIL

VOUBILJETVIR khloris® Relief OLIE

OIL

SO