Product Leaflet - Schlaf (Sleep)
ORISUN
SLEEP (SCHLAF)
PRODUCT LEAFLET
PROFESSIONAL INFORMATION
SCHEDULING STATUS: S0
1. NAME OF THE MEDICINE:
Sleep 250mg & 750mg & 1500mg (Oral Spray)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION:
Actives: Each 15ml bottle contains 250mg or 750mg or 1500mg of cannabinoids of cannabidiol (CBD).
Each spray contains 2.7mg or 8.3mg or 16.6mg of Cannabidiol (CBD) respectively.
Sugar free. For the full list of excipients, see Section 6.1.
PHARMACOLOGICAL CLASSIFICATION: Complementary Medicine Western Herbal Medicine
3 PHARMACEUTICAL FORM: Transparent, yellow oil.
4 CLINICAL PARTICULARS:
4.1 Therapeutic Indications:
Sleep may help relieve stress and anxiety.
Not for persons under the age of 18.
4.2 Posology and method of administration:
Do not exceed the maximum dose of 20mg CBD per day.
Sleep (15ml) Spray: Take 1 – 6 sprays respectively sublingually after food mornings and/or evenings. Shake well before use. Duration of use: No longer than 3 months without advice from a relevant health care provider.
Paediatric population: The safety and efficacy of Sleep in children has not yet been established.
Method of Administration: Take sublingually as is.
4.3 Contraindications:
- Avoid use of CBD with clobazam, stiripentol or valproate. Please see section 4.5 for more information.
- The use of CBD together with opioids and caffeine should be avoided.
- Known hypersensitivity to the active substance or to any of the excipients is listed under Section 6.1.
- Not to be taken during pregnancy and lactation. Please see section 4.6 for more information.
- Not to be taken by children under the age of 18 years.
4.4 Special Warnings and Precautions for Use:
If you are taking other medicines on a regular basis always consult your doctor, pharmacist, or other health care practitioner before taking CBD. The use of CBD in moderate or severe hepatic impairment may cause an increase in liver enzymes. Please see section 4.8 (b). CNS Depressants: Consult your doctor or health care practitioner as concomitant use of cannabidiol may cause enhanced therapeutic or adverse effects.
4.5 Interactions with Other Medicines:
CBD may interact with numerous medicines. Taking CBD may (theoretically) cause additive effects when taking sedatives or anaesthetics enhancing the effect of the sedatives beyond what is intended. CBD inhibits Cytochrome P450 (CYP) system in vitro. The effect of CBD in humans has not been fully established. Co-administration of CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir or clarithromycin) or inducers (e.g., rifampicin, carbamazepine, phenytoin, phenobarbital, or St. John’s wort) may affect medication levels. Clobazam: Do not take in combination. The concomitant use of cannabidiol and Clobazam is associated with an increase in lethargy. Valproate: Do not take in combination. Causes potential elevation of liver transaminases. Interaction with Diseases: Oral preparations of cannabidiol (CBD) taken at doses more than 20mg per day may worsen symptoms of Parkinson’s disease. Other Herbs and Supplements: Use of cannabidiol with other herbs and supplements may cause additional therapeutic and adverse effects.
Interaction with Food: Taking cannabidiol with a high fat meal or high calorie meal enhances uptake in the body compared to taking cannabidiol on an empty stomach. Not to be taken with alcohol.
4.6 Fertility, Pregnancy and Lactation:
Do not take during pregnancy or lactation. No data is available for the effects of Cannabidiol on fertility.
4.7 Driving and Operating Machinery:
Taking CBD may cause light-headedness, dry mouth, or drowsiness. Do not drive or operate machinery until you know how CBD affects you.
4.8 Undesirable Effects:
a) Summary of Safety Profile:
Cannabidiol is well tolerated when taken orally. Drowsiness, dry mouth, and in a few cases, some patients experience diarrhoea, weight loss, constipation and vomiting. If symptoms persist or get worse, consult a relevant health care provider for advice.
b) Summary of Adverse Effects:
Psychiatric Disorders/Nervous System: Causes sedation and lethargy. Drowsiness is noted when used with Clobazam.
Hepato-biliary Disorders: When taken orally, cannabidiol can cause elevated liver transaminase levels.
Adverse effects appear to be dose dependent and more common in patients who already have elevated transaminase levels and most common in patients already taking Clobazam or valproic acid. Adverse effects have been reported to be clinically mild or insignificant, except for some patients taking cannabidiol with valproic acid have experienced significant elevation of liver transaminase levels requiring discontinuation of either valproic acid or cannabidiol.
c) Description of Adverse Reactions:
Cannabidiol oil can cause dry mouth, diarrhoea, decreased appetite, weight loss, drowsiness, fatigue, vomiting and elevated liver transaminase enzyme levels. Doses of more than 15-20 mg/kg daily have been associated with an increased occurrence of diarrhoea, decreased appetite, weight loss and transaminase elevations.
d) Children: CBD is not recommended for use in children. Please consult your doctor.
Other Special Populations: No clinical data available Overdose: Treatment is symptomatic and supportive.
5. PHARMACOLOGICAL PROPERTIES:
5.1 Pharmacodynamic Properties:
Mechanism of Action: Cannabidiol interferes and interacts with some endocannabinoid and non-endocannabinoid signalling systems. The uptake and metabolism of the endocannabinoid anandamide is inhibited by cannabidiol.
5.2 Pharmacokinetic Properties:
Absorption: Cannabidiol is absorbed through the small intestine and is subject to significant first pass effect. Cannabidiol is estimated to have a bioavailability of 13-19% in humans. Distribution: Cannabidiol and its metabolites are more than 94% protein bound. Oil based cannabidiol solutions shows a large volume of distribution after oral administration.
Metabolism: Cannabidiol is metabolised by hydroxylation, oxidation, beta-oxidation, conjugation, and epoxidation. Conjugation with fatty acids enhances lipophilicity and uptake in the tissues. Excretion: The estimated elimination half-life of an oil based cannabidiol solution is 58 hours and is excreted primarily in the faeces with little or no cannabidiol in the urine.
5.3Preclinical Safety Data:
Cannabidiol has been found to have a low toxicity rating. WHO ATC Class Code: N03AX24
6. PHARMACEUTICAL PARTICULARS:
6.1. List of Excipients: Sleep (15ml) Oral Spray:
MCT Oil (Capric/Caprylic Triglycerides), Linalool, Myrcene, Longifolene, Cherry & Dark Chocolate Flavoring.
6.2. Incompatibilities: CBD must not be mixed with other medicines or preparations.
6.3. Shelf Life: 24 months
6.4. Special Precautions for Storage: Store in a cool, dry place below 25 0C. Store upright and away from sunlight. Do not store in the refrigerator. KEEP OUT OF REACH OF CHILDREN.
6.5. Packaging: Sleep is a clear, yellow oil, packed in a amber glass bottle with a black screw spray cap.
6.6. DETAILS OF APPLICANT:
ORISUN
6.7. REGISTRATION NUMBER:
To be allocated
6.8. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION:
Not applicable.
6.9 DATE OF REVISION OF THE TEXT:
03.01.2025
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS: S0
Sleep Spray 15ml Cannabidiol (CBD) Sugar free
Category D 33.6: Complementary Medicine Western Herbal Medicine
This unregistered medicine has not been evaluated by the South African Health Products Regulatory Authority (SAHPRA) for its quality, safety or intended use. Important Notice: Read All Information Carefully Before Use:
Sleep is available without a doctor’s prescription for health and wellbeing. CBD must be used with care for the best effect.
- Keep this leaflet for future reference.
- Do not share this preparation with other people.
- Always consult your doctor or pharmacist if unsure about use.
Contents:
1. What Sleep contains and what it is used for.
2. What you need to know before taking CBD.
3. How to use CBD.
4. Possible side effects.
5. How to store CBD.
6. Contents of the pack and other information.
1. Use of CBD.
Sleep may help relieve stress and anxiety.
2. What you need to know before taking CBD Care Relieving.
CBD may interact with numerous medicines. Consult your health care provider before starting CBD if you are taking any other medicine, particularly antifungals, ARVs, antibiotics, TB medicines, anti-epileptic, anti-depressant, and herbal medicines.
Do not use CBD if you are using:
- Anti- epileptic medication: clobazam, stiripentol or valproate.
- Anti-depression medication or sleeping tablets. CNS Depressants: Consult your doctor or health care practitioner as concomitant use of cannabidiol may cause enhanced therapeutic or adverse effects.
- If you are hypersensitive (allergic) to CBD or any of the ingredients listed in Section 6.
Taking CBD may (theoretically) cause additive effects when taking sedatives or anaesthetics enhancing the effect of the sedatives beyond what is intended. CBD inhibits Cytochrome P450 (CYP) system in vitro. The effect of CBD in humans has not been fully established. Co-administration of CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir or clarithromycin) or inducers (e.g., rifampicin, carbamazepine, phenytoin, phenobarbital, or St. John’s wort) may affect medication levels.
Oral preparations of CBD taken at doses more than 20mg per day may worsen symptoms of Parkinson’s disease.
The use of CBD together with opioids and caffeine should be avoided. Hepatic Impairment: The use of CBD in moderate or severe hepatic impairment may cause an increase in liver enzymes. Other medicines and CBD: Always tell your health care provider if you are taking any other medicine. (This includes all complementary and traditional medicines).
CBD with food and alcohol: Fat and fat containing foods may enhance the effects of CBD. Do not take CBD with alcohol.
Pregnancy and Breastfeeding: Do not take during pregnancy and breastfeeding.
Driving or Using Equipment or Machines Taking CBD may cause light-headedness, dry mouth, or drowsiness. Do not drive or operate machinery until you know how CBD affects you.
3. How to use CBD.
Do not share medicines prescribed for you with another person.
Always use CBD as indicated in this leaflet or as prescribed by your healthcare professional if you are unsure. Do not exceed the maximum dose of 20mg CBD per day.
Sleep(15ml) Spray
Take 1 - 6 sprays under the tongue (sublingually) after food in the mornings and/or evenings. Shake well before use.
Not for use by persons under the age of 18. The safety and efficacy of CBD in children has not yet been established.
If you take more CBD than you should:
There are no known cases of overdose. In case of over dosage, consult your doctor or pharmacist. If neither are available, contact the nearest hospital or poisons centre.
If you forget to take CBD: Take your next dose at the usual time. Do not take a double dose to make up for a missed dose.
4. Possible Side Effects.
CBD can have side effects. Not all side effects are reported in this leaflet. Should your general health deteriorate or if you experience any adverse effects when taking CBD, consult your healthcare provider.
Frequent Side Effects:
CBD can cause drowsiness. This can be worse when taken at the same time as other medicines with sedative properties, including herbal or traditional medicines.
Less Frequent Side Effects:
CBD can cause dry mouth, and in a few cases, some patients experience diarrhoea, weight loss, constipation, and vomiting.
Reporting Side Effects:
If you experience side effects consult your health care professional. You can also report your side effects to SAHPRA via the “6.04 Adverse Drug Reporting Form”, found online under SAHPRA publications: https//www.sahpra.org.za/Publications/Index/8.
By reporting side effects, you can help provide information about safety.
5. Storage of CBD.
Store in a cool, dry place below 25 0C.
Store upright and away from sunlight. Do not store in the fridge.
KEEP OUT OF REACH OF CHILDREN.
Return all unused medicines to your pharmacist. Do not flush unused medicines in the drains or toilet.
6. Contents of the Pack and Other Information.
Sleep 15ml (oral spray) contains:
MCT Oil (Capric/Caprylic Triglycerides), Linalool, Myrcene, Longifolene, Cherry & Dark Chocolate Flavoring.
What does Sleep look like and contents of the pack.
Sleep 15ml are a transparent, yellow oil, packed in a amber glass bottle with a black screw spray cap.
DETAILS OF APPLICANT:
ORISUN
THIS LEAFLET WAS LAST REVISED IN:
09 March 2023
REGISTRATION NUMBER:
To be allocated.