Introduction About CANEURA STRAWBERRY FLAVOUR ORAL SOLUTION

CANEURA STRAWBERRY FLAVOUR Oral Solution  contains cannabidiol, which can be used to manage epilepsy. It is also indicated for use as adjunctive therapy of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), or tuberous sclerosis complex (TSC) in patients 1 year of age and older.

Do not take CANEURA STRAWBERRY FLAVOUR Oral Solution if you are allergic to cannabidiol or any of the other ingredients of this medicine. Inform your doctor if you have or have had liver problems.  Your physician might perform blood tests to check liver function,

CANEURA STRAWBERRY FLAVOUR Oral Solution  is an oral solution (a liquid to be swallowed). Your doctor will tell you how much to take each day, how many times a day you should take it and which syringe you should use for your dose (1 ml or 5 ml). Your doctor will calculate the dose according to your body weight.

The most common side effects are feeling drowsy or sleepy, diarrhoea, decreased appetite, fever, vomiting  and feeling tired.

Uses Of CANEURA STRAWBERRY FLAVOUR ORAL SOLUTION

• to manage epilepsy.
• as adjunctive therapy of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), or tuberous sclerosis complex (TSC) in patients 1 year of age and older.

How CANEURA STRAWBERRY FLAVOUR ORAL SOLUTION Works

The precise mechanisms by which cannabidiol exerts its anticonvulsant effects in humans are unknown. Cannabidiol reduces neuronal hyper-excitability through modulation of intracellular calcium via certain receptors (G protein-coupled receptor 55 (GPR55) and transient receptor potential vanilloid 1 (TRPV-1) channels) through inhibition of adenosine cellular uptake via the equilibrative nucleoside transporter 1 (ENT-1).

How to use CANEURA STRAWBERRY FLAVOUR ORAL SOLUTION

Always take this medicine exactly as instructed by the physician. CANEURA STRAWBERRY FLAVOUR Oral Solution is to be administered orally. The physician will calculate the dose according to the body weight.

The commonly recommended dosage for seizures associated with Lennox-Gastaut syndrome or Dravet syndrome is:

• The starting dosage is 2.5 mg/kg twice daily (5 mg/kg/day).

• After one week, the dosage can be increased to a maintenance dosage of 5 mg/kg twice daily (10 mg/kg/day).

• The physician might increase the daily dose up to 10 mg/kg twice daily (20 mg/kg/day).

 The commonly recommended dosage for seizures associated with tuberous sclerosis complex is:

• The starting dosage is 2.5 mg/kg twice daily (5 mg/kg/day).

• After one week, the dosage can be increased in weekly increments of 2.5 mg/kg twice daily (5 mg/kg/day), as tolerated.

• The physician might increase the daily dose to the recommended maintenance dosage of 12.5 mg/kg twice daily (25 mg/kg/day).

Taking CANEURA STRAWBERRY FLAVOUR Oral Solution with food can increase the amount of medicine the body takes in.

What if I forgot to take CANEURA STRAWBERRY FLAVOUR ORAL SOLUTION

If you/your child forget to take CANEURA STRAWBERRY FLAVOUR Oral Solution If you/your child forget to take a dose, do not take a double dose to make up for a forgotten dose. Take the next dose at the regular time. If you/your child have missed many doses, please talk to your physician about the correct dose to take.

Overdose

Do not exceed the recommended dose. Do not reduce the dose or stop taking this medicine unless the physician tells you to. CANEURA STRAWBERRY FLAVOUR Oral Solution is a long term treatment. Keep taking until your physician tells you to stop.

If you have accidentally taken a higher dosage If you have taken more CANEURA STRAWBERRY FLAVOUR Oral Solution than you should, consult your physician immediately. If a child consumed an overdose or consumed it by mistake, consult immediately with your physician or attend the emergency room at the nearest hospital and bring the medicine with you. Signs of overdose include diarrhoea and sleepiness.

Side Effects Of CANEURA STRAWBERRY FLAVOUR ORAL SOLUTION

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

Common side effects:

• feeling drowsy or sleepy
• diarrhoea
• decreased appetite
• fever
• vomiting
• feeling tired
• seizures
• feeling bad-tempered (irritable, aggressive)
• rash
• lack of energy
• cough, pneumonia
• weight loss
• feeling sick
• urinary tract infection

 The following side effects could be very serious: -

• High liver enzymes (transaminases elevations) seen in blood tests, which can be a sign of liver injury, have been reported in patients receiving CANEURA STRAWBERRY FLAVOUR Oral Solution  
• People taking this medicine can have thoughts of harming or killing themselves.

Warning & Precautions

Pregnancy

Monitoring required

There are only limited data from the use of cannabidiol in pregnant women. Studies in animals have shown reproductive toxicity. As a precautionary measure, cannabidiol should not be used during pregnancy unless the potential benefit to the mother clearly outweighs the potential risk to the foetus.

Breastfeeding

Contraindicated

There are no clinical data on the presence of cannabidiol (CBD) or its metabolites in human milk, nor on its effects on breastfed infants or milk production. Animal studies have shown toxicological changes in lactating animals treated with CBD. Although no human studies have been conducted on CBD excretion into breast milk, its high protein binding and likely transfer from plasma to milk suggest that, as a precaution, breastfeeding should be discontinued during management.

Driving and Using Machines

Use with Caution

Talk to your doctor about driving, using machines or when children undertake activities such as cycling or other sports, because you may feel sleepy after taking this medicine.

Alcohol

Contraindicated

Using the medicine with alcohol Combining this medicine with alcohol is not recommended. Alcohol could potentiate the sleepiness and sedation effects of CANEURA STRAWBERRY FLAVOUR Oral Solution

Kidney

Consult your doctor

Cannabidiol can be administered to patients with mild, moderate, or severe renal impairment without dose adjustment. There is no experience in patients with end-stage renal disease.

Liver

Consult your doctor

Cannabidiol does not require dose adjustment in patients with mild hepatic impairment

Caution should be used in patients with moderate (Child-Pugh B) or severe hepatic impairment (Child-Pugh C). A lower starting dose is recommended in patients with moderate or severe hepatic impairment.

Allergy

Contraindicated

CANEURA STRAWBERRY FLAVOUR Oral Solution  is not recommended to use if you are allergic to cannabidiol or any other ingredients of this medicine.

Use In Pediatrics

Contraindicated

CANEURA STRAWBERRY FLAVOUR Oral Solution  is not recommended for use in children under the age of 2 years.

Use In Geriatrics

Use with Caution

Clinical trials of CANEURA STRAWBERRY FLAVOUR Oral Solution in the treatment of seizures associated with LGS, DS, and TSC have not included a sufficient number of patients aged above 55 years to determine whether or not they respond differently from younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy

Other Warnings for CANEURA STRAWBERRY FLAVOUR ORAL SOLUTION

Before taking CANEURA STRAWBERRY FLAVOUR Oral Solution  inform your doctor if

• you have or have had liver problems
• you notice unusual changes in your mood or behaviour or have thoughts of harming or killing yourself
• you experience weight loss or are unable to gain weight

Who should not take [GBNKEYWORD

CANEURA STRAWBERRY FLAVOUR Oral Solution   is not recommended to use if:

• your doctor determines that you have certain abnormal liver blood tests.

Drug - Drug interaction

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

• other epilepsy medicines, such as carbamazepine, clobazam, lamotrigine, lorazepam, phenytoin, stiripentol and valproate
• other medicines used to manage TSC, including everolimus or tacrolimus
• medicines used to manage acid reflux (heartburn or acid regurgitation) such as omeprazole
• mitotane (a medicine used to manage tumours in the adrenal gland)
• morphine or diflunisal (medicines used to manage pain)
• efavirenz (a medicine used to manage HIV/AIDS)
• theophylline (a medicine used to manage asthma)
• caffeine (a medicine for babies who need help breathing)
• propofol (an anaesthetic used for people undergoing surgery)
• simvastatin, fenofibrate, gemfibrozil, (medicines used to reduce cholesterol/lipids)
• enzalutamide (a medicine to manage prostate cancer)
• bupropion (a medicine to help stop smoking or for obesity)
• St. John’s wort (Hypericum perforatum) (a herbal medicine used for mild anxiety)
• medicines for bacterial infections, such as rifampin, clarithromycin and erythromycin

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