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Circle Medical Cannabis

Consumer Medicines Information (CMI)

  • What is in the leaflet?
    This leaflet answers some common questions about Circle Balance 1:1. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits, if you have any concerns about taking this medicine, ask your doctor or pharmacist.
  • What is medicinal cannabis oil?
    Pharmaceutical grade, natural, plant-based medication, containing full-spectrum cannabis concentrates diluted in MCT oil. Each product contains a combination of the active ingredients CBD (cannabidiol) and THC (delta-9-tetrahydrocannabinol). Ingredients are cultivated and extracted from cannabis plants that have been specifically bred and grown to suit relevant medical conditions. Cannabis oils are designed for oral administration to achieve accuracy of dosing and a longer-lasting effect.
  • Medicine Name
    Circle Balance 1:1 Cannabis Oil, 30mL
  • Medicine Description
    Each Medicinal Cannabis Oil bottle contains: 10 mg/mL CBD (Cannabidiol) 10 mg/mL THC (Delta-9-Tetrahydrocannabiol) Circle Balance 1:1 is not registered on the Australian Register of Therapeutic Goods (ARTG). No specific indications are approved for the use of this product. Circle Balance 1:1 is only available via the Special Access Scheme (SAS) or the Authorised Prescriber (AP) scheme.
  • Indications
    Circle Balance 1:1 does not have approved indications. However, the Therapeutic Goods Administration (TGA) has approved Medicinal Cannabis SAS applications for indications including, but not limited to the following; - Anxiety-related disorders - Chronic pain - Rheumatological conditions - Paediatric epilepsy - Depression - Insomnia - Multiple sclerosis - PTSD - IBS - Crohn’s Disease - Parkinson’s Disease Circle Balance 1:1 should be used to treat specific medical conditions and symptoms determined by your Medical Practitioner.
  • Contraindications
    Circle Balance 1:1 may be contraindicated in patients: - With hypersensitivity to cannabinoids or any of the excipients - Who are pregnant, planning to become pregnant or lactating - Who have a known history of schizophrenia or significant psychiatric disorder other than depression - Who have severe, unstable cardiovascular disease
  • Side-effects
    All medicines may have unwanted side effects. Sometimes they are serious, but most of the time they are not. As for other medicines of this type, many side effects tend to be minimal and reduce over time. These side effect may include, but are not limited to: - Nausea and vomiting - Dizziness - Vertigo - Fever - Diarrhoea - Convulsions - Feelings of euphoria - Confusion - Impaired coordination - Changes in appetite - Drowsiness and sedation - Impaired short-term memory - Dry mouth - Hives - Psychosis Your doctor has weighed the risks of this medicine against the benefits they expect it will have for you. The extent of side effects will vary between individuals. Stop using Circle Balance 1:1 and talk to your Medical Practitioner if you experience any negative side effects.
  • Safety
    - Tell your doctor if you have allergies to other medicines or have had any medical conditions - Tell your doctor if you have used cannabis previously - Do not drive or operate heavy machinery while after using Circle Balance 1:1 - Avoid combining Medicinal Dried Cannabis with other CNS depressants like benzodiazepines, sedatives and alcohol. Using Circle Balance 1:1 at the same time as sedatives may cause impairment or adverse effects. - If you experience any signs of allergic reaction like skin rash, hives, swelling of the face, lips, tongue, difficulty breathing or shortness of breath, urgently call your doctor. If you have consumed Circle Balance 1:1 and are experiencing particularly harmful side effects, immediately stop using it and speak with your Medical Practitioner. In the event of an adverse event please contact the Therapeutic Goods Administration (www.tga.gov.au/reporting-problems).
  • Dosage and administration
    Dosage is dependent on the specific medical condition, do not use Circle Balance 1:1 without dosage and administration advice from your Medical Practitioner. When using Medicinal Cannabis Oil, there is an extended onset time and longer duration of effects. Each bottle of Circle Balance 1:1 includes a dropper to aid dosing. It is recommended to start on a low dose and titrate the dose up slowly. The optimal dose is the lowest dose that achieves the highest benefit.
  • Instructions for use
    - Unscrew the cap on the bottle and insert the tip of the dropper into the bottle opening - Draw up the prescribed dosage into the dropper by squeezing the dropper head, the black line should align with the prescribed dosage - Aim the tip of the dropper into the mouth and depress the dropper head, swallow the dose - Wash the syringe by separating the plunger from the barrel and wash with warm, clean water. Allow it to dry before the next dose
  • Overdosage
    The signs of overdose may include, but are not limited to: - Ataxia - Psychotic episode - Chest pain - Rapid heartbeat - Respiratory depression - Nausea and vomiting - Severe anxiety attack - Severe panic attack - Slurred speech Children are at greater risk of poisoning. For more information on the management of overdose, contact the Poisons Information Centre on 13 11 26.
  • Storage
    Keep your medicine in a secure area out of reach of children. Keep your medicine in a cool, dry place where the temperature stays below 25°C. Use within the expiry date as indicated on the label.
  • Sponsor
    Montu Group PTY LTD Level 18, 1 Nicholson St East Melbourne VIC 3002 Tel: 1800 844 920 | email: circle@montu.com.au
  • Date of information
    This information was prepared on January 2021 Version 1.0
  • WARNING
    THIS MEDICINAL CANNABIS PRODUCT IS A SCHEDULE 4 POISON: PRESCRIPTION ONLY MEDICINE POSSESSION WITHOUT AUTHORITY IS ILLEGAL. KEEP OUT OF REACH OF CHILDREN. If you have any other questions about Circle Balance 1:1, please talk to your Medical Practitioner.

Consumer Medicines Information (CMI).

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