100 mg / ml oral cannabidiol solution

Read all of this leaflet carefully before you or your patient starts taking this medicine. It contains information that is important to you or the patient.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Epidyolex is and what it is used for 
2. What you or the patient need to know before taking Epidyolex 
3. How to take Epidyolex 
4. Possible side effects 
5. How to store Epidyolex 
6. Contents of the packaging and other information 

1. What Epidyolex is and what it is used for

Epidyolex contains cannabidiol, a drug that can be used to treat epilepsy, a condition that causes seizures.

Epidyolex is used in combination with clobazam, or combination with clobazam and other drugs against epilepsy, for the treatment of seizures occurring at two rare diseases, Dravet syndrome, and Lennox-Gastaut syndrome. It can be used for adults, adolescents, and children from 2 years of age.

2. What you or the patient need to know before taking Epidyolex

Do not take Epidyolex

  • if you are allergic to cannabidiol or any of the other ingredients of this medicine (listed in section 6).
  • if your doctor determines that you have certain abnormal liver values ​​on blood tests.

Warnings and cautions

Talk to your doctor or pharmacist before taking Epidyolex, or during treatment, if:

  • you have or have had liver problems. Your doctor may need to change the dose ofEpidyolex or you may decide that Epidyolex is not suitable for you. Your doctor may take blood samples to check your liver before and during treatment, as Epidyolex may cause liver problems. If the liver is not working properly, treatment may need to be stopped.
  • you notice any unusual changes in your mood or behavior, or if you have thoughts of harming yourself or committing suicide. Contact your doctor or go to the hospital immediately (see section 4).
  • Epidyolex makes you sleepy. Do not drive a car or other vehicles, do not use machines, or engage in activities that require you to be attentive and have good motor skills, e.g. cycling, until you know how Epidyolex affects you.
  • you abruptly stop taking Epidyolex.
  • your seizures come more often or if you have a severe seizure while taking Epidyolex. Contact your doctor or go to the hospital immediately.

Children and young people

Epidyolex must not be given to children under 2 years of age as there is no information on its use in children under 2 years of age.

Other medicines and Epidyolex

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Taking Epidyolex with certain other medicines can cause side effects and the medicines can affect each other. Do not start or stop taking other medicines without first talking to a doctor or pharmacist.

Tell your doctor if you are taking any of the following medicines as the dose may need to be adjusted:

  • other drugs for epilepsy , e.g. carbamazepine. clobazam, lamotrigine, lorazepam, midazolam, phenytoin, stiripentol, and valproate used for seizures
  • heartburn medicines (acid reflux), e.g. omeprazole
  • mitotane (for the treatment of tumors in the adrenal glands)
  • morphine or diflunisal (painkillers)
  • efavirenz (for the treatment of HIV / AIDS)
  • theophylline (for the treatment of asthma )
  • caffeine (medicine for babies who need help with breathing)
  • propofol (anesthetic/sedative used in surgery)
  • simvastatin, fenofibrate, gemfibrozil (to lower cholesterol and blood fats)
  • enzalutamide (for the treatment of prostate cancer)
  • bupropion (to help stop smoking or treat obesity)
  • St. John’s wort ( Hypericum perforatum ) (an herbal medicine used to treat mild anxiety)
  • drugs for the treatment of bacterial infections, e.g. rifampin, clarithromycin, and erythromycin.

Epidyolex with food

Always take Epidyolex exactly as your doctor has told you, always take it with or without food. This also applies to diets with high-fat meals (so-called ketogenic diet). (See also section 3 “How to take Epidyolex”).

Pregnancy, breastfeeding, and fertility

If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should only take Epidyolex during pregnancy if your doctor determines that the benefits of treatment outweigh the risks.

You should not breast-feed while taking Epidyolex as Epidyolex is likely to pass into breast milk.

Driving and using machines

Talk to your doctor about driving or using machines, or if children should engage in activities such as cycling or other sports, as this may make you drowsy.

You should not drive, use machines or engage in activities that require attention and good motor skills until you know that your ability to do so is not affected.

Epidyolex contains sesame oil, alcohol (ethanol), and strawberry flavors (including benzyl alcohol)

Epidyolex contains refined sesame oil which in rare cases may cause severe allergic reactions.

This medicine contains 10 vol% ethanol (alcohol), ie up to 700 mg per dose (for an adult weighing 70 kg), equivalent to 14 milliliters (ml) of beer or 6 ml of wine per dose. May be harmful to people suffering from alcoholism. The alcohol content should be paid attention to by pregnant women, children, and high-risk groups such as patients with liver disease.

In children under 6 years of age, alcohol can have effects such as drowsiness, behavioral changes, concentration problems, and difficulty participating in school activities.

How to take Epidyolex

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Epidyolex is an oral solution (a liquid to be swallowed). Your doctor and pharmacist will tell you how much (number of milliliters) Epidyolex to take each day, how many times a day to take it, and which syringe to use for your dose (1 ml or 5 ml).

Your doctor will calculate the dose based on your body weight. You can start with a low dose which your doctor will then gradually increase. Contact your doctor if you are not sure how much to take or if you think your dose needs to be changed.

Taking Epidyolex with food may increase the number of medicines taken up by the body. As far as possible, try to take Epidyolex, in the same way, every day when it comes to meals. Take Epidyolex with or without food every day so that you get the same effect from the medicine every time.

Tell your doctor if you have liver problems as your doctor may need to adjust someone.

Do not reduce the dose and do not stop taking the medicine unless your doctor tells you to.

How to take Epidyolex orally (by mouth)

The package contains the following

  • A bottle of Epidyolex oral solution
  • A plastic bag with two oral dosing syringes of 1 ml and a bottle adapter
  • A plastic bag with two oral dosing syringes of 5 ml and a bottle adapter

A spare syringe of each size is included in the package in case the first syringe breaks or disappears.

1. Open the bag containing the oral dosing syringe you are going to use to measure dose one.

  • If your dose is 1 ml (100 mg) or less, use the small 1 ml syringe.
  • If your dose is greater than 1 ml (100 mg), use the larger 5 ml syringe.
  • If your dose is greater than 5 ml (500 mg), you must use the larger 5 ml syringe more than once. In this case, you must keep a close eye on how many times you have filled the syringe (eg by dotting each 5 ml dose ) so that you take the correct dose.

You must use the correct dosing syringe to measure dose one. Your doctor or pharmacist will tell you which syringe to use for the prescribed dose. Follow the instructions of your doctor or pharmacist. The bag containing the other syringes and the adapter (ie those you do not need for your dosing ) should be discarded according to the instructions unless your doctor or pharmacist tells you to save both syringe sizes until you have reached your escalated dose.

2. Remove the child-resistant cap from the bottle by pushing it downwards while turning it counterclockwise.

3. Push the bottle adapter firmly into the neck of the bottle. Make sure it is fully inserted. The adapter may come loose and cause suffocation if not fully inserted.

4. Press down on the tip of the dosing syringe you are going to use in the bottle adapter. Leave the syringe in place and turn the bottle upside down.

5. Slowly pull the plunger out of the syringe so that the amount of solution (number of ml) needed is drawn into the syringe. The end of the plunger should be level with the volume marking on the syringe, see the picture.

If there is an air bubble in the syringe, push the liquid back into the bottle, still with the bottle upside down. Then repeat step 5 until the bubble is gone.

6. Turn the bottle over again and carefully remove the syringe from the adapter.

7. Place the syringe tip against the inside of the cheek and gently press on the plunger so that the medicine is sprayed out. Do not press hard on the plunger. Do not aim the medicine far into the mouth or throat.

If dose one is more than 5 ml, repeat steps 4 to 7 for the remaining dose one. Use the 5 ml syringe.

8. Screw the child-resistant cap back onto the bottle firmly by turning it clockwise. The bottle adapter does not need to be removed, the lid fits on top of the adapter.

9. Fill a glass or mug with warm soapy water and clean the dosing syringe by pulling the water in and out using the plunger.

10. Pull the plunger completely out of the syringe body and rinse both parts under the tap. Do not place the dosing syringe in the dishwasher.

Shake off the water from both parts and let them air dry for the next use. Make sure that the dosing syringe is completely dry before using it again, otherwise, it may make the solution look cloudy if water enters the bottle.

If the solution in the bottle has become cloudy, it does not affect its effect. Continue to use the medicine as usual.

If you or your patient have taken too much Epidyolex

If you have taken more Epidyolex than you should, tell your doctor or pharmacist immediately, or contact your nearest emergency department and take the medicine with you. Signs that you have taken more Epidyolex than you should include diarrhea and drowsiness.

If you or your patient have forgotten to take Epidyolex

If you miss a dose, do not take a double dose to make up for a forgotten dose. Take the next dose at the usual time. If you miss many doses, talk to your doctor about which dose you should take.

If you or your patient stop taking Epidyolex

Do not reduce the dose and do not stop taking Epidyolex without talking to your doctor first. The doctor explains how to gradually stop taking Epidyolex.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects can be very serious :

  • High liver enzymes (elevated transaminases ) in blood samples, which may be signs of liver damage, have been reported in patients taking Epidyolex.
  • People taking this medicine may have thoughts of harming themselves or committing suicide. If you ever have such thoughts, consult a doctor.

You may experience the following side effects from this medicine. Talk to a doctor if you get any of the following:

A very common side effect is (can occur in more than 1 in 10):

  • drowsiness or drowsiness
  • decreased appetite
  • diarrhea
  • fever
  • fatigue
  • vomiting.

Common adverse s (can occur in more than 1 in 100):

  • powerlessness
  • cold, sore throat
  • infection of the respiratory tract ( pneumonia, bronchitis )
  • blood tests show an increase in certain liver enzymes (may be a sign of liver damage)
  • tremors in all or parts of the body
  • bad mood (irritability, aggression)
  • difficulty sleeping
  • cough
  • rash
  • increased appetite, weight loss
  • dredging
  • urinary tract infection
  • indignation
  • abnormally behaving.

5. How to store Epidyolex

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the bottle. The expiration date is the last day of the specified month.

If there is a solution left in the bottle when more than 8 weeks have passed since it was first opened, it should not be used.

No special storage instructions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is cannabidiol. Each ml of oral solution contains 100 mg of cannabidiol.
  • The other ingredients are refined sesame oil, anhydrous ethanol, sucralose, and strawberry flavoring (including benzyl alcohol).

What the medicine looks like and the contents of the pack

Epidyolex is a clear, colorless yellow oral solution. It is packaged in a bottle with a child-resistant cap, together with two identical 5 ml or 1 ml oral dosing syringes, and two bottle adapters used with the syringes. The 5 ml syringes are graduated in 0.1 ml increments and the 1 ml syringes in 0.05 ml increments.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

GW Pharma (International) BV,

Databankweg 26, 3821AL Amersfoort, The Netherlands

info@gwpharm.com

Manufacturer

GW Pharma (International) BV,

Databankweg 26, 3821AL Amersfoort, The Netherlands

info@gwpharm.com

GW Pharma Limited,

Kent Science Park, Sittingbourne, Kent, ME9 8AG, UK

info@gwpharm.com


Contact the representative of the marketing authorization holder to find out more about this medicine:

Belgium / Belgique / Belgien Lithuania
Tel: +31 (0) 337981015 Tel: +31 (0) 337981015
Bulgaria Luxembourg / Luxemburg
Phone: +31 (0) 337981015 Tel: +31 (0) 337981015
Czech Republic Hungary
Tel: +31 (0) 337981015 Tel .: +31 (0) 337981015
Denmark Malta
Tel: +31 (0) 337981015 Tel: +31 (0) 337981015
Germany The Netherlands
Tel: +49 (0) 3022957821 Tel: +31 (0) 337981015
Eesti Norway
Tel: +31 (0) 337981015 Tel: +31 (0) 337981015
Greece Austria
:Ηλ: +31 (0) 337981015 Tel: +31 (0) 337981015
Spain Poland
GW Pharma Spain, SL Tel .: +31 (0) 337981015
Tel: + 34-914197379
France Portugal
Tel: +33 (0) 170755854 Tel: +31 (0) 337981015
Croatia Romania
Tel: +31 (0) 337981015 Tel: +31 (0) 337981015
Ireland Slovenia
Tel: +31 (0) 337981015 Tel: +31 (0) 337981015
Iceland Slovak Republic
Phone: +31 (0) 337981015 Tel: +31 (0) 337981015
Italy Finland / Finland
GW Pharma Italy SRL Puh / Tel: +31 (0) 337981015
Tel: +39 (0) 687501801
Latvia United Kingdom
Tel: +31 (0) 337981015 Tel: +44 (0) 1223 238170

Muhammad Nadeem

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