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Aelleve Balance25

Summary


Click here to view the full CMI. If you are worried about using this medicine, speak to your doctor or pharmacist.

This medicine is new or being used differently. Please report side effects. See the full CMI for further details

1. Why am I using Aelleve Balance25?

Aelleve Balance25 contains the active ingredients delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). Aelleve Balance25 is not approved for any specific indication and should only be used to treat specific conditions or symptoms authorised by your healthcare practitioner.
For more information, see Section 1. Why am I using Aelleve Balance25? in the full CMI.

2. What should I know before I use Aelleve Balance25?

Do not use if you have ever had an allergic reaction to cannabis or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use Aelleve Balance25? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Aelleve Balance25 and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Aelleve Balance25?

Only a doctor/nurse practitioner can start you on treatment with Aelleve Balance25.

Use the amount of Aelleve Balance25 directed by your doctor. Follow your doctor’s instructions and use Aelleve Balance25 until your doctor tells you to stop. If you do not understand the instruction on the pharmacist dispensing label, ask your doctor/nurse practitioner or pharmacist for help.

Your doctor/nurse practitioner will assess you from time to time to see if you should continue taking Aelleve Balance25. More instructions can be found in Section 4. How do I use Aelleve Balance25? in the full CMI.

 

5. What should I know while using Aelleve Balance25?

Things you should do

  • Remind any doctor, nurse or pharmacist you visit that you are using Aelleve Balance25.
  • You should use Aelleve Balance25 under medical supervision.
  • Talk to your healthcare provider if you do not feel better, or if you feel worse.
  • You must tell your doctor if you have or have had any allergies to cannabis or cannabis-based

    medicines.

  • You must tell your doctor if you have or have had any problem with your liver, kidneys, heart, gut,

    substance use disorder (abuse, dependence), or any other medical condition.

  • Tell your doctor if you have or have had any psychotic or concurrent disorder.
  • If you are about to start any new medicine, tell your doctor/nurse practitioner and pharmacist that

    you are taking Aelleve Balance25

Things you should not do

• You should not start taking any other medicines without first informing your doctor.
• You should not use this medicine if you are pregnant or plan to become pregnant or are breastfeeding. • Do not stop taking this medicine suddenly
• Do not take this medicine to treat any other complaint unless advised by your doctor
• Do not give this 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 Balance25
• Aelleve Balance25 may impair your concentration, ability to think and make decisions, and your

reaction time and coordination. This can affect your motor skills and ability to drive and operate machinery.

Drinking alcohol

• Alcohol may increase the effects of Aelleve Balance25 and you should avoid taking it while taking this medicine.

• Alcohol taken in combination with Aelleve Balance25 can impair your cognitive abilities, coordination, reaction time and motor skills.

Looking after your medicine –

Your medicine should be stored in its original labelled packaging, in a safe and secure place away from your medicine children, and away from heat and direct sunlight (i.e. stored in a cool, dry place, at or below 25°C).

For more information, see Section 5. What should I know while using Aelleve Balance25? in the full CMI.

6. Are there any side effects?

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. You are more likely to get side effects when you start your treatment. They are usually mild and wear off within a few hours.
Do not be alarmed by these lists of possible side effects. You may not experience any of them. Ask your doctor/nurse practitioner or pharmacist to answer any questions you may have.

There are a number of side effects associated with this medicine. It is important to be aware of them so that you can identify any symptoms if they occur.

Tell your doctor if you notice any of the following common mild side effects and they worry you:

• fatigue and sedation
• dizziness
• nausea

• dry mouth
• increase in appetite

Tell your doctor/nurse practitioner immediately or go to the Emergency Department at your nearest hospital if any of the following serious side effects happen:

  • thoughtsofsuicide
  • rapidheartbeat
  • chestpain
  • convulsion
  • hallucinations
  • psychosis
  • you develop signs of allergy such as swelling of the face, lips, mouth, tongue, throat or other parts of the body; shortness of breath or difficulty breathing; rash, itching or redness on the skin.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

Full Consumer Medicine Information (CMI)


Warning! This leaflet provides important information about using Aelleve Balance25. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Aelleve Balance25.

Active ingredient(s): delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD)

This page provides important information about using Aelleve Balance25. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Aelleve Balance25

1. Why am I using Aelleve Balance25?

Aelleve Balance25 contains the active ingredients delta-9- tetrahydrocannabinol (THC) and cannabidiol (CBD).

Aelleve Balance25 is not approved for any specific indication and should only be used to treat specific conditions or symptoms authorised by your doctor.

Aelleve Balance25 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 Balance25 may vary between individuals.

Ask your doctor if you have any questions about why Aelleve Balance25 has been prescribed for you.

2. What should I know before I use Aelleve Balance25?

Warnings
Do not use Aelleve Balance25 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.

3. What if I am taking other medicines?

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 Balance25. 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 Balance25 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 Balance25.

Avoid taking Aelleve Balance25 with alcohol and/or other CNS depressants/sedatives including prescription medications, e.g., benzodiazepines. Using Aelleve Balance25 at the same time as alcohol and/or other sedative drugs may cause more severe levels of impairment and adverse effects.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Aelleve Balance25.

4. How do I use Aelleve Balance25?

How much to take / use

  • Aelleve Balance25 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 Balance25 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 Balance25 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 Balance25, 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 Balance25 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.

    When to take / use Aelleve Balance25

    • Aelleve Balance25 should be used as directed by your doctor.
    • This product can be taken with or without food, but it may be absorbed better with a fatty substance.

      How to administer Aelleve Balance25

    • 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 Balance25

      If you think that you have used too much Aelleve Balance25, you may need urgent medical attention.

      You should immediately:

    • phone the Poisons Information Centre (by calling 13

      11 26), or

    • contact your doctor, or go to the Emergency Department at your nearest hospital.

      You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using Aelleve Balance25?

Things you should do

• Take Aelleve Balance25 as your doctor has prescribed. • Remind any doctor or pharmacist you visit that you

are using Aelleve Balance25.
• Tell your doctor if your symptoms do not improve. • Take special care if you drink alcohol while using

Aelleve Balance25. Using Aelleve Balance25 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 Balance25.
  • Need to have medical tests while you are taking Aelleve Balance25. 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 Balance25 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 Balance25
    Aelleve Balance25 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 Balance25 since alcohol may increase the effects of Aelleve Balance25 that impair your cognitive abilities, reaction time, coordination, and motor skills.

    Travelling overseas with Aelleve Balance25

    Before going to a foreign country check if it is legal for you to travel with Aelleve Balance25 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.

6. Are there any side effects?

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.

Less serious side effects

What to do

  • daytime drowsiness
  • dizziness
  • fatigue
  • dry mouth
  • dry eyes
  • headache
  • increased appetite
  • difficulty concentrating
  • nausea
  • memory impairment
  • blurred vision
  • constipation or diarrhoea
  • euphoria

Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

What to do

Allergy-related:

  • swelling of the face, lips, mouth,tongue, or throat which may

    cause difficulty in breathing

  • Shortness of breath or difficultyin breathing
  • Skin reaction which may includerash, itching, redness, blistering

    or peeling of the skin Cardiovascular:

  • rapid heartbeat
  • chest pain
  • low blood pressure/feeling faint Brain/Nervous system:
  • convulsions
  • numbness
  • burning sensation
  • vomiting
  • loss of coordination balance
  • disorientation
  • confusion
  • depression
  • agitation
  • hallucinations
  • psychosis
  • thoughts of suicide General:
  • Upper respiratory infection
  • Strong abdominal pain

Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

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

Other side effects not listed here may occur in some people.

Reporting side effects

If you experience any side effects, talk to your healthcare provider or pharmacist. This includes any possible side effects not listed in this leaflet.

By reporting side effects, you can help provide more information on the safety of this product. After you have received medical advice for any side effects you experience, you can report side effects to Lyphe Australia on 1800 890 379 or via info@lypheaustralia.com.au, or to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

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

Active ingredient (main ingredient)

delta-9 tetrahydrocannabinol 10mg/mL, cannabidiol 10mg/mL

Other ingredients (inactive ingredients)

Medium chain triglyceride (coconut derived), minor cannabinoids, terpenes and flavonoids

Potential allergens – Cannabis plant, Medium Chain Triglycerides (coconut derived)

Do not take this medicine if you are allergic to any of these ingredients.

What Aelleve Balance25 looks like

Aelleve Balance25 is provided as an amber liquid in a brown glass 30 mL bottle. An adapter is fitted into the neck of the brown glass bottle which fits a graduated 1.0ml syringe for easy measurement of doses

Who distributes Aelleve Balance25

Lyphe Australia Pty Ltd
351 Moray Street, South Melbourne, VIC, 3205 Phone: 1800 329 059
Email: info@lypheaustralia.com.au
Website: www.lypheaustralia.com.au

Aelleve Balance25 is a Schedule 8 medicine: CONTROLLED DRUG Possession without Authority Illegal.

Aelleve Balance25 is not listed on the Australian Register of Therapeutic Goods (ARTG) and can only be accessed via a Special Access Scheme (A or B) or an Authorised Prescriber scheme or through a registered clinical trial

This leaflet was updated in January 2024.

Aelleve Balance25 is not listed on the Australian Register of Therapeutic Goods (ARTG) and can only be accessed via a Special Access Scheme (A or B) or an Authorised Prescriber scheme or through a registered clinical trial