Patient Information Leaflet Medicinal Cannabis oil

Cannabiszorg

(Trading under Apotheek SMA)

THC 2,0% (Sativa) oil
THC 2,0% (Indica) oil
CBD 2,0% / THC 1,3% (Sativa) oil
CBD 10% (From purified CBD) oil
CBD 5% / THC 10% (Sativa)

For sublingual application

Read all of this patient information leaflet carefully before you start using medicinal cannabis oil because it contains important information for you.

  • This medicine has been prescribed for you only. Usage by others may be harmful to them, even if their symptoms are similar to yours.
  • Do you experience discomfort from one or more of the side effects listed under column 5? Or do you experience side effects not listed in this information leaflet? Please contact your doctor or pharmacist.
  • Do you have any other questions? Please contact the Cannabiszorg pharmacist.
  • Keep this information leaflet. You may need to refer to it while using this medicine.

1. Medicinal cannabis

Cannabis consists of the dried flowers of the female Cannabis sativa L plant, also known as hemp or marijuana. Cannabis contains a number of active substances, like dronabinol (THC) and cannabidiol (CBD). THC is mainly responsible for the effects of cannabis, but others – like CBD – may also influence the effectiveness of the drug. The chemical composition of the cannabis determines the effects and side effects. Cannabis dispensed by pharmacies complies with the strictest quality standards and is intended for medicinal use only. Therefore, it is called medicinal cannabis and medicinal cannabis oil.

2. What is medicinal cannabis oil used for?

There are several varieties of medicinal cannabis which have different compositions and strengths, and thus different effects. Of these varieties we prepare three different types of medicinal cannabis oil. Each variety has its own predetermined strength and composition. It is also possible to combine varieties and methods of administration.

THC 2,0% (Sativa) oil
The THC 2,0% (Sativa) oil is made from a cannabis sativa strain. Cannabis with high levels of THC is preferred for disorders such as Gilles de la Tourette syndrome, therapy-resistant glaucoma and symptoms like weight loss, nausea and vomiting.

THC 2,0% (Indica) oil
The THC 2,0% (Indica) oil is made from a cannabis indica strain. This type of oil has besides the common effects of cannabis, such as pain relief, an extra strong relaxing or sedating effect on the body and mind. This can be effective for patients with pain and muscle spasms. Cannabis with high levels of THC is preferred for disorders such as Gilles de la Tourette syndrome, therapy-resistant glaucoma and symptoms like weight loss, nausea and vomiting.

CBD 2,0% / THC 1,3% (Sativa) oil and CBD 5,0% / THC 10% (Sativa) oil
What variety is best depends on the symptoms. For example: there is research data which indicates that using cannabis with a high CBD content (like CBD 2,0% / THC 1,3% (Sativa) oil or CBD 5,0% / THC 10% (Sativa) oil) provides effective relief for pain and muscle spasms in patients with multiple sclerosis (MS). Because of the anti-inflammatory properties of CBD, this variety may be more effective than others for patients with inflammatory conditions. In case of chronic neural pain, CBD 2,0% / THC 1,3% (Sativa) oil is often prescribed first. If this provides insufficient relief, an oil with a higher THC content may be substituted (CBD 5,0% / THC 10% (Sativa) oil).

CBD 10% (From purified CBD) oil
The CBD 10% (From purified CBD) oil is used for the treatment of epilepsy. This cannabis oil contains less than 0,1% THC. The undesirable psychoactive effects of ‘getting high’ are not present. Therefore, this oil is also suitable for prescription to children.
Your doctor together with your pharmacist will discuss and determine with you, which medicinal cannabis oil is best suitable in your case.

Which medical disorders?
There is sufficient reason to believe that medicinal cannabis can help in cases of:

  • Pain and muscle spasms or cramps associated with multiple sclerosis or spinal cord damage
  • Nausea, loss of appetite, weight loss and debilitation due to cancer or AIDS
  • Nausea and vomiting associated with chemotherapy or radiotherapy used in the treatment of cancer, hepatitis C or HIV infection and AIDS
  • Chronic pain (mainly pain associated with the nervous system, for example that caused by a damaged nerve, phantom pain, facial neuralgia or chronic pain which remains after the recovery from shingles)
  • Gilles de la Tourette syndrome
  • Therapy-resistant glaucoma.

Daarnaast komen er steeds meer gegevens en positieve berichten van patiënten en artsen beschikbaar over de werkzaamheid van cannabis bij andere aandoeningen. Alleen zijn daarvan de wetenschappelijke bewijzen nog onvoldoende. Voorbeelden hiervan zijn de ziekte van Crohn, colitis ulcerosa, epilepsie, jeuk, migraine, reuma, reumatoïde artritis, ADHD en hersentrauma (zie ook www.cannabis-med.org).

Patients and doctors have also reported positive effects on a range of other conditions, including Crohn’s disease, ulcerative colitis, epilepsy, itching, migraine, rheumatism, rheumatoid arthritis, ADD and brain trauma. These positive effects still need to be confirmed by scientific research. (For more information, go to www.cannabis-med.org.) At present, medicinal cannabis does not cure the disorders mentioned above, but it can relieve the symptoms associated with them. It may also enable other medication to be given at a lower dosage, and reduce their side effects. It is up to doctors to determine whether treatment with medicinal cannabis would benefit a patient, given his or her diagnosis and circumstances. In doing so, they are not limited to the list of conditions given above. A doctor may only prescribe medicinal cannabis if the standard treatments and registered medicines are not having the desired effect or are causing too many side effects.

3. How do you use medicinal cannabis oil?

You will typically start with a low dosage. If the effect is insufficient, you will gradually increase the dosage after consultation with your doctor or pharmacist.

THC 2,0% (Sativa) oil
THC 2,0% (Indica) oil
CBD 2,0% / THC 1,3% (Sativa) oil
CBD 5,0% / THC 10% (Sativa) oil
Start with 1 drop under the tongue 2-3 times a day. If the effect is insufficient, gradually increase the number of drops. Typically, 3-4 drops of oil a day are tolerated well. The dose and effects can vary individually.

The taste, if required, can be neutralized by eating some olives or a slice of banana after application of drops under the tongue. The percentage CBD and THC in our medicinal cannabis oils remains the same from bottle to bottle.

Example incremental dosage scheme:
Day 1-2: 2-3 times a day 1 drop
Day 3-4: 2-3 times a day 2 drops
Day 5-6: 2-3 times a day 3 drops
Day 7-8: 2-3 times a day 4 drops
Day 9 and further: in consultation with your doctor

CBD 10% (from purified CBD) oil, 10 ml for epilepsy (10% = 100 mg/ml)

Dosage: Start with 0.2 mg/kg/day in 2 divided doses. The dosage can be gradually increased until the desired effect is reached or to the maximum dose of 25 mg/kg/day in 2 divided doses. The oil is applied under the tongue.

The taste, if required, can be neutralized by eating some olives or a slice of banana after application of drops under the tongue. The percentage CBD and THC in our medicinal cannabis oils remains the same from bottle to bottle.

Example incremental dosage scheme children:
Week 1: 0,5 mg/kg/dag in 2 divided doses
Week 2: 1 mg/kg/dag in 2 divided doses
Week 3: 2 mg/kg/dag in 2 divided doses
Week 4: 3 mg/kg/dag in 2 divided doses
Week 5: 4 mg/kg/dag in 2 divided doses
From week 6: 5 mg/kg/day in 2 divided doses
The neurologist determines whether the dosage will be increased further.

Example incremental dosage scheme adults:
Day 1-3: 0,1 ml per day in 2 divided doses
Day 4-6: 0,2 ml per day in 2 divided doses
Day 7-10: 0,3 ml per day in 2 divided doses
Day 11-13: 0,4 ml per day in 2 divided doses
Day 14-17: 0,5 ml per day in 2 divided doses
Day 18 and further: if required gradually increase with 0,1 mL

What is the duration of the effects?
When medicinal cannabis oil is applied under the tongue, the effects will occur rapidly (typically within 30 minutes). The maximum effect is usually achieved after 2-3 hours, and it takes 4-8 hours to wear off. It takes 4-5 days to clear all the active components from the body.

How long do I have to use the medicine?
Use the medicinal cannabis oil for as long as symptoms persist if you experience no relief of symptoms after 1-2 weeks, consult with your doctor or Cannabiszorg. It is possible that you need an increase in dosage or change the type of medicinal cannabis oil. It is also possible that medicinal cannabis oil is not an effective treatment for you.

Have you used too much medicinal cannabis oil?
The effect is temporary and it takes 4-8 hours to wear off.

What do I have to do when I forget a dose?
It is not serious if you forget a dose. If you have been using the medicine for several weeks already at a high dose, you may experience withdrawal symptoms.

  • If you are using this medicine 1 time a day: take the forgotten dose nonetheless. Wait 8 hours before taking the next dose.
  • If you are using this medicine 2 times a day: take the forgotten dose nonetheless. Wait 4 hours before taking the next dose.

4. When are you not allowed to use medicinal cannabis oil and what should you be aware of?

You are not allowed to use medicinal cannabis if you have congenital long QT syndrome or predisposition to psychotic disorders. Medicinal cannabis should be avoided with Brugada- syndrome as this can lead to an abnormal ECG. Caution is warranted with patients diagnosed with other mental health disorders, Cardiac arrhythmia, angina pectoris and ischemic heart disease. In all these cases consult with your doctor or pharmacist prior to use.
Pregnancy and breastfeeding
Continuous use of cannabis during pregnancy can affect the foetus. Also, certain components of cannabis – like THC – end up in breast milk. That is why the use of medicinal cannabis is not advisable during pregnancy and while breastfeeding. For more information, consult your doctor or pharmacist.
Food and beverages?
There are no dietary restrictions. Avoid drinking grapefruit juice as this can slow the metabolism of active cannabis components. To ensure a rapid onset of effects, you should apply drops of medicinal cannabis oil under the tongue. The taste, if required, can be neutralized by eating some olives or a slice of banana after application of drops under the tongue.

Drinking alcohol?
Combining alcohol with cannabis increases the intensity and the duration of the effects of both. Therefore, reduce alcohol consumption and preferably avoid drinking alcohol altogether when using medicinal cannabis oil. Do NOT operate a vehicle after drinking alcohol in combination with cannabis.

Driving a car?
With daily usage of medicinal cannabis oil, you are not allowed to drive a car for the first two weeks. With occasional usage you are not allowed to drive a car until 15 hours after your last dosage. It may be dangerous to participate in traffic while using medicinal cannabis oil. If you experience side effects like getting ‘high’, drowsiness, languor, dizziness, euphoria, confusion, hallucinations or fear, do not drive a car.

Taking medicinal cannabis oil abroad?
The use of medicinal cannabis is subject to restrictions laid down in the Opium Act. This means you must follow certain rules when using medicinal cannabis. In the Netherlands possession of medicinal cannabis is allowed – if prescribed by a doctor and dispensed by a pharmacy. This does not apply for most other countries, however. If you are travelling to a Schengen country and want to take medicinal cannabis along, you need a declaration (Schengenverklaring) from the CIBG, part of the Ministry of Health, Welfare and Sport. The CIBG’s website (www.farmatec.nl) has more information about this. If you are travelling to a country outside the Schengen area, you must contact the embassy or the consulate of the country in question for permission to take the medicinal cannabis with you. You should allow plenty of time for your application to be processed.

5. What are the potential side effects?

Besides the desired effects medicinal cannabis may also lead to side effects. These side effects usually disappear after a few hours. Patients generally tolerate medicinal cannabis well. A low dosage often provides sufficient relief, so that side effects rarely occur. When they do, it is usually the result of a high dosage or combined use with a substance such as alcohol that intensifies the side effects.

The most important side effects are the following.

THC 2,0% (Sativa) oil
THC 2,0% (Indica) oil
CBD 2,0% / THC 1,3% (Sativa) oil
CBD 5,0% / THC 10% (Sativa) oil

 

Regularly

  • ‘High’-feeling, this is a feeling of euphoria which slowly subsides into feeling satisfied, peaceful and calm. The altered perception may cause you to feel confused. Other effects are: relaxation, fits of laughter, feeling hungry, heightened sensitivity to the perception of e.g. colour and music, lethargy and distorted temporal and spatial awareness. Your reaction time may also be slower, especially during the first hours after use.

Sometimes

  • Downcast mood, mainly affects the elderly, and feelings of fear, panic and confusion. This usually occurs after taking a high dose or when you use cannabis for the first time. Therefore, it is advisable to be in a calm place and preferably have someone present when using cannabis for the first time.
  • Cannabis can worsen existing mental health problems, such as schizophrenia (psychosis). You may experience hallucinations (delusions). Please consult your specialist before using medicinal cannabis.
  • If you experience excessive restlessness and insomnia, consult your doctor or Cannabiszorg.

Rare

  • Dizziness, headache, warm or cold hands and feet, red irritated eyes and a dry mouth. These effects usually disappear after a few hours.
  • Heart palpitations, rapid heartbeat, increased blood pressure and chest pain. In rare cases this can result in myocardial infarction. The chance of this occurring increases at high dosage. If you have angina pectoris, medicinal cannabis can worsen your symptoms. If this occurs contact a doctor. The cardiac effect typically disappear after 1 hour. Patients with congenital cardiac disorders, such as long QT syndrome or Brugada-syndrome may experience more severe cardiac side effects and should NOT use medicinal cannabis.

Very rare

  • High dosages of medicinal cannabis taken over a longer period may lead to addiction. Quitting may then cause withdrawal symptoms, such as mild forms of restlessness, irritability, insomnia and nausea. Please consult your doctor if you experience discomfort from one of the abovementioned side effects, or if you experience any other side effects that cause you to worry.

Do you experience discomfort from a side effect?
Inform both the Cannabiszorg pharmacist and the side effects monitoring centre Lareb. This centre monitors all cases of medicine side effects in the Netherlands.

CBD 10% (from purified CBD) oil
Not much is known about the potential side effects of CBD. However, CBD is not psychoactive and therefore does not lead to a ‘high’. It is not likely to provoke a psychotic episode.

Addiction

THC 2,0% (Sativa) oil
THC 2,0% (Indica) oil
CBD 2,0% / THC 1,3% (Sativa) oil
CBD 5,0% / THC 10% (Sativa) oil

Addiction is unlikely with cannabis used as a medicine. The recommended dose is usually lower than that for recreational use. You should take particular care if you have had an addiction problem in the past.

High dosages of medicinal cannabis taken over a longer period may lead to addiction. Quitting may then cause withdrawal symptoms, such as mild forms of restlessness, irritability, insomnia and nausea.

CBD 5,0% / THC 10% (Sativa) oil
Based on current knowledge it is primarily THC that causes the addictive potential of medicinal cannabis. Dependence on CBD is not expected.

6. May I use medicinal cannabis oil in combination with other medication?

The medications that cause the most significant interactions with medicinal cannabis are medications that reduce the reaction time. The medications that reduce reaction time contain a yellow warning sticker in The Netherlands. The effects on for instance your ability to drive will mutually increase. Do not drive a car when you use 2 or more medicines that reduce reaction time. The cannabinoids in the medicinal cannabis oil are metabolised in the liver. Therefore, some medications may cause interactions with medicinal cannabis oil. Also, drinking grapefruit juice may alter the metabolism of cannabinoids in the liver. Grapefruit juice should be avoided while taking medicinal cannabis oil.

If you are using anticoagulants like acenocoumarol and Phenprocoumon (fenprocoumon), you are only allowed to use medicinal cannabis oil if you are under supervision of the thrombosis service (trombosedienst).

Medicinal cannabis oil has potential interactions with phenytoin (fenytoine) and carbamazepine. This combination is only allowed when you are monitored by a neurologist.

The Cannabiszorg pharmacist will check whether medicinal cannabis oil is compatible with the rest of your medication.

7. How do you store medicinal cannabis oil?

Store medicinal cannabis oil out of reach and sight of children. After opening medicinal cannabis oil, store in a refrigerator (2-8°C). Do not use medicinal cannabis oil after the expiration date. The expiration date can be found on the label on the packaging. Ask your pharmacist what to do with unused medicinal cannabis oil.

8. Additional information

What compounds are in this medicine?

  • The active compounds of medicinal cannabis oil are THC and/or CBD. Look at the label to see which active compounds are present in the oil. CBD 10% (from purified CBD) does not contain THC.
  • The other compound in this medicine is refined almond oil.

What does the packaging look like and how much medicine does it contain?
Medicinal cannabis oil is a golden yellow to light-brown oil.

  • 10 ml THC 2,0% (Sativa) oil contains 20 mg THC per ml
  • 10 ml THC 2,0% (Indica) oil contains 20 mg THC per ml
  • 10 ml CBD 2,0% / THC 1,3% (Sativa) oil contains 20 mg CBD per ml and 13 mg of THC per ml
  • 10 ml CBD 5,0% / THC 10% (Sativa) oil contains 50 mg CBD per ml and 100 mg of THC per ml
  • 10 ml CBD 10% (From purified CBD) oil contains 100 mg CBD per ml

The medicinal cannabis oil is packaged per 10 ml in a brown glass bottle with a screwcap dropper.

This information is published by Cannabiszorg, based on the patient information flyer provided by the BMC (www.cannabisburea.nl).

This patient information leaflet was updated/approved in October 2017.

Trading under Apotheek SMA
De Kleine Elst 20 | 5246JH | Rosmalen
Telefoon: +31 (0)73 648 0343
info@cannabiszorg.nl
www.cannabiszorg.nl