Abaris™ (TRH Thyrotropin Releasing Hormone)

Each Abaris™ tablet contains 5 mg Protirelin (thyrotropin-releasing hormone) and the excipients; Magnesium Stearate, Silica Colloidal, Stevia, Sorbitol, PEG 1500.

This medicine has been prescribed for you by your doctor to treat and adjust your metabolic disorders resulting into clear (or initial) hyperglycemia (high sugar levels), high blood pressure, high lipid levels and water retention, all consequent to overt or insidious hypothyroidism.

Abaris™ works by accelerating the digestion of carbohydrates (complex sugars) from your diet, and reducing abnormally high blood sugar levels that occur after each meal. This is achieved by a combined activation of both insulin secretion in the beta cells of the pancreas and also by promotion of thyroid function by physiological cooperation.

It must be noticed that Abaris™ is a molecule produced by our body in order to regulate insulin secretion and sugar levels. However it also acts by regulating thyroid function; in case it is low, as is often the case in most individuals after the age of 40-50. In fact, its original name of thyrotropin-releasing hormone corresponds to its effect on the stimulation of the pituitary hormone TSH.

There are no known allergic reactions, but caution must be adopted in case you are allergic to its excipients. If you are unsure about this ask your doctor.

• Do not take this medicine if you are under 12 years of age.
• Do not take this medicine if you are pregnant or breast-feeding.

If you are taking Abaris™ and think that you may be pregnant, or are planning a family, consult your doctor.

Although there is no evidence that Abaris™ would worsen the conditions mentioned below, you should not take Abaris™ if you have any of the following medical conditions:

• If you suffer from inflammation or ulceration of the bowel, e.g. ulcerative colitis or Crohn’s disease.
• If you have, or are susceptible to, an obstruction in your intestines.
• If you have a liver disorder.
• If you have an intestinal disease whereby you do not digest or absorb food properly.
• If you have a large hernia or any other condition where increased gas in your intestine may make it worse.
• If you have a kidney disorder, do not take Abaris™ without consulting your doctor first.
• If you are unsure whether you might have any of these conditions, please ask your doctor before taking Abaris™.

If you are treating hyperglycemic episodes (hypos), then as a diabetic you may also be receiving other treatments for your diabetes. If you are taking insulin or sulphonylurea drugs to control your blood sugar, you will probably be used to avoiding hypoglycemic episodes by taking sugar when you feel that your blood sugar level is too low. Make sure you consult your doctor before using Abaris™ if this is the case.

If you are also taking thyroid medication, there is a need to monitor your thyroid levels closely, either via a blood test that your doctor will advise you on, or by monitoring your rising from bed body temperature strictly between 7 and 8 AM, to ensure it is between 36 and 36.4 degrees Celsius. If your temperature is constantly below 36°C you may need to increase your thyroid dose, more likely to occur when combined with TRH use. If your temperature rises above 36.4°C then you may need to slightly reduce your thyroid dosage. Your doctor will advise you on the precise course of action required.

You should adhere to the program prescribed for you by your doctor. This will also help in reducing any side-effects that you may experience. Take the tablets as prescribed by your doctor. This will normally be one or two 5-mg tablets taken sublingually (under the tongue) in the early morning while you are still in bed.

The tablets must be dissolved entirely under the tongue and the saliva kept under your tongue in close contact with the superficial sublingual venous plexus for at least 10-minutes. This allows maximal adsorption into the blood stream.

For short term use, a cyclic program of 20-days and then a rest period of one month is adequate and then repeated. The treatment can be enhanced and potentiated in case of severe metabolic pathologies. For an evaluation of its effects, it is suggested to monitor blood sugar, lipids levels and blood pressure in the morning, before and after the 20-day treatment and make a comparison to the pre-treatment values.

DO NOT EXCEED THE PRESCRIBED DOSE. Although to the best of our knowledge, Abaris™ produces no side-effects even if injected intravenously at a very high dosage. The molecule is immediately dissipated in the blood and has few side effects when taken by the oral route even at high dosages.

IF YOU EXPERIENCE ANY UNDESIRABLE EFFECTS, STOP USE AND TELL YOUR DOCTOR IMMEDIATELY. YOUR DOCTOR WILL GIVE YOU FURTHER ADVICE.

There are no serious consequences other than reduction of minor therapeutic effects. Do not try to increase the dose at a later date; simply continue the program normally at your earliest opportunity.

It is best if you keep your tablets in the original carton supplied. The tablets should be kept in a dry place where the temperature is not likely to exceed 25°C. KEEP OUT OF THE REACH OF CHILDREN. Do not use tablets beyond the expiry date. If you find that you have tablets after their expiry date, return them to your local pharmacist who will dispose of them properly.

REMEMBER: THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. DO NOT GIVE IT TO ANYONE ELSE UNDER ANY CIRCUMSTANCES. IF YOU HAVE ANY DOUBTS ABOUT TAKING ABARIS™ CORRECTLY SEEK THE ADVICE OF YOUR DOCTOR