Aelleve Balance10

Aelleve Balance10 contains the active ingredients delta-9- tetrahydrocannabinol (THC) and cannabidiol (CBD).

Aelleve Balance10 is not approved for any specific indication and should only be used to treat specific conditions or symptoms authorised by your doctor.

Aelleve Balance10 is an alternative therapeutic option when standard of care treatments have not been beneficial.

This medicine is only available with a doctor’s prescription and approval via the TGA special access scheme or authorised prescriber scheme.

The therapeutic benefit of Aelleve Balance10 may vary between individuals.

Ask your doctor if you have any questions about why Aelleve Balance10 has been prescribed for you.

Warnings
Do not use Aelleve Balance10 if:

• If you are allergic to cannabis extracts or any of the

  other ingredients of this product.

• If you are pregnant, planning to become pregnant or

  breastfeeding. THC and CBD can pass into your breastmilk if you are breastfeeding. It may affect your baby.

  Check with your doctor or pharmacist if you:

  • If you have a serious heart problem such as angina, a previous heart attack, poorly controlled high blood pressure or a problem with your heart rate or heart beat.

  • If you have a personal history of serious mental disorders, such as schizophrenia or psychosis, unless specifically prescribed by a qualified healthcare provider aware of your psychiatric disorder.

  • If you have epilepsy or regular fits (seizures).
  • If you have serious liver or kidney disease.
  • If you are less than 18 years of age.
  • If you have previously abused any drug or substance

  There may be other contraindications not yet known due to limited scientific information.

  During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

  Pregnancy and breastfeeding

  Check with your doctor if you are pregnant or intend to become pregnant.

  Talk to your doctor if you are breastfeeding or intend to breastfeed.

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

You should also tell any health professional who is prescribing a new medication for you that you are taking Aelleve Balance10. If you see a different doctor or go into hospital, let them know all the medicines you are taking.

Some medicines may interfere with Aelleve Balance10 and affect how it works.

These medicines include warfarin and other blood thinners, strong pain killers and other medicines used for anxiety, depression, epilepsy and sleep aids. This list is not exhaustive. If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before using Aelleve Balance10.

Avoid taking Aelleve Balance10 with alcohol and/or other CNS depressants/sedatives including prescription medications, e.g., benzodiazepines. Using Aelleve

How much to take / use

• Aelleve Balance10 can be taken on a metered dosage schedule or as needed (PRN) as determined by your healthcare provider.
• A titration period may be required to reach optimal dose.
• The amount of Aelleve Balance10 you use each day will depend on your response and tolerability to the product.
• Your doctor will provide you with a treatment schedule based on your needs.
• Always use Aelleve Balance10 exactly as instructed by your healthcare provider or pharmacist. Check with your healthcare provider or pharmacist if you are not sure.
• During the use of Aelleve Balance10, you should be under medical supervision to help you determine if the product is working or if you are having any side effects from the treatment.
• Effects from Aelleve Balance10 may begin within approximately 60-90 minutes after you take a dose and may last for about 6-9 hours, depending on the dose you took, how long you have been taking this medication and individual response
• Do not exceed the recommended dosage.

  How to administer Aelleve Balance10

  • Unscrew the cap located on the bottle
  • Insert the tip of the syringe into the bottle adaptor

    and press down firmly.

  • Turn the bottle upside down and draw the prescribed

    dose of oil up into the syringe.

  • Return the bottle and syringe to the upright position

    and remove the syringe from the bottle.

  • Position the syringe under the tongue and push the

    syringe plunger to dispense the dose.

  • Wash the syringe by separating the plunger from the

    barrel and washing with warm water. Allow to dry completely before next use.

    If you use too much Aelleve Balance10

    If you think that you have used too much Aelleve Balance10, you may need urgent medical attention.

    You should immediately:

Things you should do

• Take Aelleve Balance10 as your doctor has prescribed. • Remind any doctor or pharmacist you visit that you

are using Aelleve Balance10.
• Tell your doctor if your symptoms do not improve. • Take special care if you drink alcohol while using Aelleve Balance10.

Using Aelleve Balance10 and alcohol together may increase their effects (such as loss of balance or ability to respond quickly).

Call your doctor straight away if you

• Are pregnant or become pregnant while taking Aelleve Balance10.
• Need to have medical tests while you are taking Aelleve Balance10. It may affect the results of some tests.

  Things you should not do

• Do not stop using this medicine suddenly without telling your doctor. If you stop taking it suddenly or change the dose, your condition may worsen, or you may have unwanted side effects.
• Do not use Aelleve Balance10 to treat any other complaints unless your doctor tells you to.

Do not give your medicine to anyone else, even if they have the same condition as you.

Driving or using machines
Do not drive or use machinery after taking Aelleve Balance10
Aelleve Balance10 may cause you to feel sleepy or dizzy and can also slow your cognitive abilities. This can lead to decreased concentration and coordination, slowed reaction time, and impaired motor skills. These effects may be increased while taking other medicines.

Drinking alcohol
Tell your doctor or pharmacist if you drink alcohol. You should avoid alcohol while using Aelleve Balance10 since alcohol may increase the effects of Aelleve Balance10 that impair your cognitive abilities, reaction time, coordination, and motor skills.

Travelling overseas with Aelleve Balance10

Before going to a foreign country check if it is legal for you to travel with Aelleve Balance10 and/or check out smarttraveller.gov.au. This includes any countries that you will be travelling through to get to your final destination.

Looking after your medicine

• Store below 25°C, away from direct sunlight in a cool and dry place.

• Always keep your medication in its original packaging until it is time to take it.

• Refer to the product label for expiration dates.
• Keep out of reach of children.

Getting rid of any unwanted medicine

• If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.
• Do not use this medicine after the expiry date.

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions. Other side effects not listed here may occur in some people.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

This medicine is only available with a doctor’s prescription.