Revia 50 mg. 28 tablets
Please read this leaflet carefully before you start your treatment. For further information please contact your doctor or pharmacist.
What is Revia?
Revia is available in the form of a pale yellow film-coated tablets for oral use, which on one side are denoted by "R11", and the other side with "50". Each film-coated tablet contains 50 mg of active substance naltrexone hydrochloride.
Revia film-coated tablets also contain inactive ingredients: lactose monohydrate, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate coating (pale yellow opadry).
Revia is available in packs of 1, 2 or 4 blisters of 7 tablets.
Naltrexone hydrochloride is an opioid antagonist, which means that it blocks the effects of opioid agents (eg. Dihydrocodeine, morphine and heroin), as well as substances having a similar effect, naturally occurring in the brain. It is believed that alcohol increases levels of these substances in the body and creates a feeling of satisfaction. Revia blocks the effects of opioids and thus reduces dependence and craving for alcohol use. Revia not cause dependence.
The active substance of Revia, naltrexone hydrochloride, is absorbed rapidly and completely from the gastrointestinal tract after oral administration. After metabolism is obtained the active metabolite 6 - beta-naltrexone. Once-daily administration, naltrexone hydrochloride is released in about 4 hours and 6 - beta-naltrexone for about 13 hours. The drug is excreted primarily through the kidneys.
In which cases Revia?
Revia not be used alone for treatment of opioid or alcohol dependence, but applies a complex with other forms of treatment (psychotherapy, behavioral therapy, psycho-social measures). Naltrexone hydrochloride reduces the craving for receiving opioids and alcohol, thereby reducing the risk of relapse.
What you should know before you start treatment with Revia?
You should not take Revia:
If you are allergic to the active substance of Revia or any of the excipients;
If you are currently taking opioid substances (in this case can occur abstinence syndrome) or are in a state of withdrawal (can worsen the condition).
If you are taking medicines that contain opioids, such as certain cough, anti-diarrheal and painkillers.
Caution: Revia not block the effects of pain-relieving drugs that do not contain the opioid (e.g., ibuprofen, acetaminophen, or aspirin).
If you are currently in a state of withdrawal symptoms from opioids;
If the test for the presence of opioids in the urine is positive;
If you experience withdrawal symptoms from opioids after injection of naloxone;
If you suffer from acute hepatitis or liver failure;
If you experience any of the above conditions or are not sure in their assessment, consult with your doctor.
There are no adequate test data and results from the use of this medicine by persons under 18 years.
Pregnancy and lactation
In studies in animals have not teratogenic effects of naltrexone. However, the drug should be used in pregnant or lactating women in urgent indications and after consideration of the potential benefits and possible risks to mother and child.
What you should tell your doctor before taking Revia?
Whether you suffer from liver or kidney disease;
Whether you are pregnant, planning a pregnancy or breast-feeding;
Whether you are taking medicines containing opioids (see above) or other drugs such as. thioridazine;
It is necessary to tell your doctor about any medication you are taking, including those obtained without a prescription.
If you experience fatigue or dizziness after taking the drug do not drive or operate machinery until you discuss the problem with your doctor.
How to take the tablets Revia?
At least 7-10 days before treatment with Revia You should stop taking any opioid substances. Your doctor should do a test (urine), which will confirm whether treatment with Revia can begin.
On the first day, said patient is administered 25 mg naltrexone hydrochloride, as observed for one hour, in order to ascertain whether there will occur withdrawal symptoms. If you do not show withdrawal symptoms, the patient is given the remaining 25 mg daily dose.
The usual dose is one tablet (50 mg naltrexone hydrochloride). This dose can block the effect of 25 mg of pure heroin intravenously administered for 24 h.
Regimen can be modified and your doctor may prescribe a different dose with which to improve the comprehensive treatment and reduce the symptoms of dependence. For example, the appointment of 2 tablets (= 100 mg naltrexone hydrochloride) on Monday and Wednesday and 3 tablets (= 150 mg naltrexone hydrochloride) on Friday.
Revia is taken by the doctor for 3 months or more.
If you take more than your prescribed dose, contact your doctor immediately. Treatment of overdose is symptomatic.
If you miss a dose, do not worry. Take your next dose as scheduled, without trying to make up for lost by doubling the dose.
What can happen if you drink alcohol during treatment with Revia?
Concomitant administration of Revia alcohol does not cause typical, unpleasant sensations (disulfiram-type reaction). If, however, continue to drink alcohol during treatment, the levels of alcohol in your blood will rise, which will lead to physical and mental disorders.
Patients taking Revia, should not apply medicines containing opioids (some antitussive, anti-diarrheal and sedation) as Revia can reduce their effects.
If necessary, the urgency of opioid analgesics is necessary to apply a higher dose in order to provide adequate analgesia. In these cases, due to the risk of respiratory depression, or manifestation of other side effects, it is necessary to monitor the patient.
If you are taking low doses of heroin or other opioids, naltrexone hydrochloride will prevent opioid effects.
What are the possible side effects?
Most patients tolerate the drug. Like other drugs, however, sometimes causes so-called Revia. adverse reactions in certain patients who may show up as symptoms of withdrawal syndrome morphine.
During treatment with Revia are marked following adverse reactions:
Stomach pain, cramps in the stomach and small intestine, nausea, vomiting, diarrhea, constipation (constipation), loss of appetite.
Headaches, sleep disorders, insomnia, mood changes (irritability, discomfort), a sense of fear, passivity, a sense of confusion, hallucinations, nervousness, dizziness, abnormal vision.
Skin rashes, itching, acne.
Increased sweating and tearing, leg pain, joint and muscle pain, ear pain, thirst, weight loss, delayed ejaculation, libido disorders;
Observed a single case of idiopathic thrombocytopenic purpura, which disappears with corticosteroid therapy;
In a study conducted in patients with drug or alcohol dependence was not observed increase in liver transaminases during treatment. In an earlier study of obese patients who received 300 mg naltrexone per day (6 times the daily dose) for a long period of time, the level of liver transaminases were elevated at some of them. The increase in liver transaminases reversible after discontinuation of treatment and may be attributed to high doses received naltrexone.
At the beginning and during the treatment, the physician's discretion, may require blood tests for opioids. This is because Revia is metabolized in the liver, and the tests are an indicator of liver function.
If you feel pain in the stomach, which lasts several days, you have loose stools, dark color of urine or yellowing of the eyes, you should immediately stop taking the drug and consult your doctor.
Patients treated with Revia should carry a card containing information on their name and surname, the drug taken and the treatment period. They should always carry the card, so that if needed in an emergency, to ensure the appropriate treatment.
Revia can block the effects of opioid containing medicines (some antitussive, anti-diarrheal and sedation). Do not try to overcome the blockade, taking higher doses of these drugs, because it can have life-threatening effects. If you become ill and need treatment, tell your doctor and / or pharmacist that you are taking Revia. They will recommend the appropriate medicine.
What is necessary to remember about Revia!
Check the expiry date of the drug. Do not use after the expiry date stated on the packaging.
Keep at temperatures below 25 ° C.
Warn your doctor that you are taking naltrexone hydrochloride.
Mould in urine naltrexone hydrochloride should not be done in cases where the patient exhibits clinical symptoms of withdrawal, or when there are traces of opioids in the urine. The test is repeated at appropriate intervals (daily) until it is established that there is no opioids in the urine. It is recommended to make regular laboratory tests to monitor the availability of opioids and other substances of abuse.
Before the beginning and during treatment with Revia recommended control of liver function (transaminase activity).
Remember that this medicine is prescribed for you should not be taken by anyone without prescription.
Take your medicine as prescribed by your doctor.
Keep out of reach of children.
When you stop taking the medication, return any unused tablets to your doctor or pharmacist.