Read all of this leaflet carefully before you start taking this medicine.
What [PRODUCT NAME] is and what it is used for
[PRODUCT NAME] contains cannabidiol (CBD), which is a compound derived from the cannabis plant. Unlike THC (tetrahydrocannabinol), CBD does not produce a "high" or intoxicating effect.
Your doctor has prescribed [PRODUCT NAME] for you because [INDICATION PLACEHOLDER]. This is an unlicensed medicine, which means it has not been granted a marketing authorisation by the UK medicines regulator (MHRA) for this specific use. Your doctor has decided that it is appropriate for your individual clinical needs.
Important: This medicine is prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
What you need to know before taking [PRODUCT NAME]
Do not take [PRODUCT NAME] if:
- You are allergic to cannabidiol or any of the other ingredients
- You have severe liver problems
- Your doctor has told you not to take this medicine
Warnings and precautions:
- Tell your doctor if you have liver problems. You will need regular blood tests to check your liver function.
- Tell your doctor about all other medicines you are taking, including over-the-counter medicines, herbal remedies, and supplements.
- Tell your doctor if you are pregnant, planning to become pregnant, or breastfeeding.
- This medicine may make you feel drowsy. Do not drive or operate machinery until you know how it affects you.
- Avoid drinking alcohol while taking this medicine, as it may increase drowsiness.
How to take [PRODUCT NAME]
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Your prescribed dose:
If you take more than you should: Contact your doctor or go to your nearest hospital emergency department immediately. Take the medicine packaging with you.
If you forget a dose: Take it as soon as you remember, unless it is nearly time for your next dose. Do not take a double dose to make up for a forgotten dose.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common side effects (may affect up to 1 in 10 people):
- Drowsiness or fatigue
- Decreased appetite
- Diarrhoea
- Changes in liver blood tests (your doctor will monitor this)
- Feeling unwell or vomiting
Serious side effects -- contact your doctor immediately if you experience:
- Yellowing of the skin or eyes (jaundice)
- Dark urine
- Severe abdominal pain
- Unusual bruising or bleeding
- Severe allergic reaction (difficulty breathing, swelling of face/throat)
Reporting Side Effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard
By reporting side effects, you can help provide more information on the safety of this medicine.
How to store [PRODUCT NAME]
- Keep this medicine out of the sight and reach of children.
- Store below 25 degrees C. Do not refrigerate or freeze.
- Do not use this medicine after the expiry date shown on the label.
- Use within [X] weeks of first opening.
- Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use.
Contents of the pack and other information
What [PRODUCT NAME] contains:
The active substance is cannabidiol (CBD). Each [UNIT] contains [DOSE] mg of cannabidiol.
The other ingredients are: [EXCIPIENT LIST PLACEHOLDER]
Your prescribing doctor:
Name: [PRESCRIBER NAME]
Clinic: [CLINIC NAME]
Telephone: [PHONE NUMBER]
Email: [EMAIL ADDRESS]