Side effects

 

As with all medicines it is important to understand the key safety information.

 

Here you can stay informed about very common side effects, precautions and special warnings for patients taking Epidyolex, and the recommended schedule for liver monitoring. For more information about side effects and warnings, refer to the Patient Information Leaflet included in the Epidyolex box.

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Adverse effects

What are the most common side effects of Epidyolex?

 

Like all medicines, Epidyolex has some side effects, although not everybody experiences them.

 

The most common side effects that occur during treatment with your medicine may affect more than 1 in 10 people and include:

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Feeling drowsy or sleepy
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Fever
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Decreased appetite
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Vomiting
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Diarrhoea
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Feeling tired
If you get any side effects, talk to your doctor, pharmacist or nurse

This includes any possible side effects not listed here or in the Patient Information Leaflet.

 

You can also report side effects directly via the Yellow Card Scheme at https://yellowcard.mhra.gov.uk

 

By reporting side effects you can help provide more information on the safety of this medicine.

 

Side effects should also be reported to GW Pharma on medinfo@gwpharm.com

Precautions whilst taking Epidyolex

 

Whilst taking Epidyolex there are a few things that you and/or your doctor should look out for or be aware of.

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Stay safe when tired

Epidyolex may cause you to feel sleepy and other medicines (e.g. clobazam) or alcohol can increase this sleepiness. Do not drive, operate heavy machinery, or do other dangerous activities until you know how Epidyolex affects you.

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Pregnancy

If you are pregnant, think you may be pregnant or are planning to have a baby, please ensure you have spoken to your doctor, nurse or pharmacist about taking this medicine. You can take Epidyolex during your pregnancy only if your doctor tells you to. You should not breast-feed whilst taking Epidyolex, as Epidyolex is likely to be present in breast milk.

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Alcohol content

This medicinal product contains 10% by volume ethanol (alcohol). For recommended doses in an adult weighing 70 kg, this is equivalent to 14 ml of beer, or 6 ml of wine per dose. The alcohol content should be taken into account in pregnant women, children and high-risk groups such as patients with liver disease or alcoholism.

 

The effects of alcohol in children under the age of 6 years old may include sleepiness, behavioural changes, and problems with concentration and taking part in school activities.

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Mood or behavioural changes

All antiepileptic medicines carry a warning for thoughts of self-harm or suicide. If you notice unusual changes in your mood or behaviour or have thoughts of harming or killing yourself contact your doctor or go to a hospital straight away.

Remember to monitor ongoing treatment

 

Your doctor will recommend regular blood tests to check your liver enzymes throughout your treatment.

 

Epidyolex may cause these to increase especially if you are also taking clobazam or valproate.

 

Monitor periodically or as clinically indicated.

Routine monitoring schedule

 

Pre-treatment
Test 1
Month one
Test 2
Month three
Test 3
Month six
Test 4
Ongoing
Consult your doctor

If your liver test results before you started treatment are too high (based on your doctor’s judgement) or you are already taking valproate, your doctor may carry out intensified monitoring instead.

 

Your doctor may also decide to carry out intensified monitoring if your dose of Epidyolex changes above 10 mg/kg/day.

Intensified monitoring schedule

 

Pre-treatment
Test 1
Two weeks
Test 2
Month one
Test 3
Month two
Test 4
Month three
Test 5
Month six
Test 6
Ongoing
Consult your doctor

References

 

1. Epidyolex Summary of Product Characteristics (Date accessed: April 2021).

 

2. Epidyolex Patient Information Leaflet (Date accessed: April 2021).