Pharmaceutical Info

Professional counseling is very important for correct and efficient treatment and supervision and guidance on dosage, potential side effects, and more. During a counseling session, the patient takes the product for the first time under the supervision and guidance of an experienced registered nurse.

 

During consumption of the treatment it is best to be seated. The treatment should be consumed three times a day (morning, afternoon, evening) and the patient should drink something sweet or eat something during use. The effects of cannabis can vary greatly from person to person, thus reaching the optimal effect should be a slow and gradual process. During the first several weeks, the dosage could slowly increase until the right dose is achieved.

When should the product not be used?

              Do not use when pregnant or nursing.

 •  Not for use if a sensitivity is known to any of the ingredients.

   Not for use if there is a personal or family history of schizophrenia or other mental illness, except depression.

   The product is not recommended for people with heart problems.

The use of this product is allowed only under license of the Ministry of Health.

Warnings:

Avoid pregnancy during the course of treatment and keep away from children. Patients should be seated while consuming the product. Changes in blood pressure and pulse rate are possible, as well as, blood sugar levels.

If the patient is currently taking medication for blood pressure, pulse or sugar, monitor changes as follows:

Check blood pressure, pulse, and blood sugar levels three times a day over the course of the first three days of use. If there are significant changes advise the patient to consult with a physician in order to find the right treatment plan.

Patients with a history of epilepsy are advised to take caution.

Do not consume with alcohol! Consuming this product with alcohol can cause a cumulative decrease in coordination, concentration, and ability to react.

Patients with a tendency for addiction can also become addicted to this product.

Warning! Extreme caution should be used in treating children. Cannabis for pediatric patients is mostly given as a supportive treatment for cancer to alleviate nausea and pain and for epileptic patients. The family should receive guidelines on initial dose and gradual increase in dosage from the treating physician.

Warning! If the patient shows signs of confusion, severe restlessness, a change in consciousness, has a psychotic episode, or has a prolonged panic attack, stop taking the product immediately.

Warning! Do not take two doses simultaneously to make up for a missed dose.

Attention! The use of cannabis may impair alertness, and therefore caution should be exercised when engaging in activities such as driving a car, operating dangerous machinery, and any other activity which requires alertness.  For more information please contact the Ministry of Health directly.

Drug Interactions:

There is a cumulative effect for cannabis in conjunction with opiates, alcohol, and sleep medications, take caution. If there is a need to use cannabis in conjunction with opiates or relaxers / sleep medication, significantly reduce the dose of the medications.

Hallucinations are possible when cannabis is taken in conjunction with SSRI anti-depressants. Significantly reduce the dose of the medication or the cannabis.

Because of the first-pass effect that happens to cannabinoids in the liver (especially when consumed orally), there is a theoretical risk in mixing cannabis with medications that are metabolized by the enzymes CYP3A4 and CYP2C9 in the cytochrome. If combining with medications that inhibit these enzymes such as: macrolides (especially clarithromycin and erythromycin), antimycotics (such as ketoconazole, fluconazole, itraconazole, and miconazole), calcium antagonists (especially diltiazem and verapamil), HIV protease inhibitors (especially ritonavir), isoniazid and amiodarone, be aware of side effects and reduce daily cannabis dose. The combination of cannabis and these medications can increase the biological availability of the cannabis and thus also increase its side effects.

Medications that inhibit the metabolism of cannabis through the enzymes mentioned above are: carbamazepine, rifampicin, troglitazone, rifabutin, primidone, phenytoin, phenobarbital and also the herbal plant Hypericum perforatum. If a patient begins treatment with these medications, there is a likelihood that an increased dose of medical cannabis will be necessary. Also, if a patient has found the appropriate dose of cannabis while taking these medications, the patient will need to reduce the dose of medical cannabis when these medications are no longer being taken.

Side Effects:

The side effects from the use of medical cannabis are not numerous and most are mild. In most cases, it is possible to treat a disease and symptoms with lower cannabis doses than the doses that generate psychotropic side effects. Cannabis may cause two categories of side effects, physiological effects such as: dizziness, irregular heartbeat (faster or slower), weakness, lower blood pressure and blood sugar levels, increased appetite, red eyes, tiredness, lack of coordination, lack of balance, and dryness in mucous membranes such as the mouth and eyes. Cognitive side effects may include: impairment to short-term memory and train of thought, as well as, an impaired perception of time and space. Regular use of large amounts (more than 5 grams per day) can lead to cognitive impairment, but this effect dissipates when use is ceased. In youth, cognitive impairment could be lasting.

Most side effects usually dissipate shortly after the patient becomes accustomed to the product. When cannabis is swallowed or dissolved in the mouth side effects could last for up to 72 hours.

Side effects that usually occur from overdose that require special attention:

Fainting, significant changes in blood pressure, in pulse, in blood sugar levels, or in respiration rates. A high dose of the product can in some cases, for people that are pre-disposed, cause a temporary psychotic attack, anxiety, delusions, or hallucinations.

It is important to note that there haven’t been long-term observations of patients that consume cannabis regularly for prolonged periods of time and the effects of cannabis on the brain are unknown.

Pharmacodynamic Properties:

Cannabinoids impact cannabinoid receptors in the body. Today, two main receptors are known, CB1 and CB2. CB1 is present mostly in the nervous system, and CB2 in the periphery, especially in the immune system and digestive system. THC binds to both of these receptors in the body. CB1 is responsible for THC’s neural properties – relaxation, pain relief (though CB2, scattered in the peripheral nerves, also contributes to pain relief), tremors, spasms, and in higher doses on psychotropic symptoms and euphoria. CB2 is responsible for the anti-inflammatory properties of cannabinoids. CBD, the main non-psychotropic cannabinoid, is active primarily on the anti-inflammatory and anti-oxidizing mechanisms.

Pharmacokinetic Properties:

Absorption: The absorption of cannabis varies based on the consumption methods. When inhaled, the cannabinoids are absorbed through the lungs to the blood stream in just a few minutes and reach a maximum concentration in the blood within 10-15 minutes. In this consumption form, the biological availability is at 40%. The absorption is heavily dependent on physiological differences among patients, the temperatures the cannabis was heated to, and the duration of the heating. Also, it is related to the gap between inhalations, the number of inhalations, the length of each inhalation, and the tolerance of the lungs. When swallowed, the cannabis is absorbed more slowly than smoking and has a larger variance from patient to patient. The maximum concentration of cannabinoids in the blood stream appear after 45 minutes to two hours (depending on the patient and whether the medication was consumed with food or without. Consumption with fatty or sweet food improves and hastens absorption). The biological availability through this intake method is about 10%, meaning just one fourth of the biological availability received through inhalation, mostly because of the first pass effect of the liver.

Dispersion: After absorption, the cannabinoids are dispersed throughout the entire body. Their concentration rises the quickest in tissues with high blood supply levels such as the brain, lungs, liver, and kidneys. Some cannabinoids accumulate in fat tissues. Cannabinoids bind strongly to plasma proteins. Their volume of dispersion is about 10 liters per kilogram of body weight.

Metabolism and discharge: In the liver, enzymes from the cytochrome family, CYP3A4 and CYP2X9 turn THC into 11-THC-hydroxy (THC-OH-11), the active metabolite, which turns into THC-carboxyl (THC-COOH) that is non-active. The half-life of THC and THC-OH-11 in the plasma is 25-36 hours. In the body, the half-life can reach up to seven days. In addition, other non-active metabolites are produced. THC metabolites are excreted in urine up to several weeks after cannabis is consumed.

Pharmacy Information:

Shelf life: Cannabis can breakdown and oxidize due to heat and moisture. Keep cannabis in its original packaging until the expiration date written on the packaging.

Storage:  Store in a cool and dark place. Close the package firmly and avoid air and moisture. Keep away from fire. Even if kept in their original packaging and stored as recommended, products may be kept for a limited period only. Please note the expiration date of the product! In case of doubt, consult the supplier.

Travel Abroad: The use of medical cannabis is permissible in certain countries, requires a permit in others and is strictly prohibited in certain countries. Before going abroad, patients are advised to check if the use of medical cannabis is permissible and to take all of the required permits and paperwork needed.

Regulation: In Israel, medical cannabis is registered under the Dangerous Drug Mandate 1973, possession and use are prohibited to those that don’t possess a license approved by the Ministry of Health.

Manufacturer:  ‘Tikun Olam’ for information and updates: www.tikun-olam.co.il For any question related to medical cannabis contact us by telephone +97235445860, fax +97235461556, or email info@tikun-olam.co.il. Dispensary is located at 183 Ibn Gabirol St. Tel Aviv, 6200715, Israel and open Sunday through Thursday from 10:00am to 5:00pm.

Guidance Center is located at 2 Brandeis St. Tel Aviv and open by appointment Sunday through Thursday from 10:00am to 3:00pm.