Suboxone. 2 mg. 0.5 mg. 7 tablets
Suboxone. 2 mg. / 0.5 mg. 7 tablets
What is Suboxone and what it is used
Suboxone is used to treat dependence on opioid (narcotic ) substances like heroin or morphine in drug addicts who have expressed consent to be treated for their addiction . Suboxone is used in adults and adolescents aged 15 years , who are also receiving medical, social and psychological support .
2 . What you should know before taking Suboxone
Do not take Suboxone
if you are allergic (hypersensitive) to buprenorphine, naloxone , or any of the other ingredients of this medicine ( see section 6) ;
if you have severe breathing problems
if you have severe liver problems ;
if you are intoxicated due to alcohol or have tremors , sweating , anxiety, confusion, or hallucinations caused by alcohol.
Warnings and Precautions
Talk to your doctor before taking Suboxone, if you have:
asthma or other breathing problems;
liver disease , such as hepatitis ;
low blood pressure ;
recent head injury or brain disease;
Urinary tract disorder (especially if associated with an enlarged prostate in men ) ;
kidney disease ;
thyroid problems ;
insufficiency of the adrenal cortex (e.g. Addison's disease ) .
Important things to note:
Misuse and abuse
This medicine may be a target for people who abuse prescription medicines , and therefore must be stored in a safe place to prevent theft. Do not give this medicine to another person. It can cause death or harm otherwise .
Some people have died of respiratory failure (inability to breathe ) as they are misused, or that medication is not taken in combination with other depressants of the central nervous system , such as an alcohol , benzodiazepines ( tranquilizers ), or other drugs .
This product can cause dependence .
This product can cause withdrawal symptoms if you take less than six hours after taking a short-acting drug (eg Suboxone may cause withdrawal symptoms if you stop taking it suddenly ) .
There have been reports of liver damage after taking Suboxone, especially improper use of the drug. This can be due to viral infections ( chronic hepatitis C), alcohol abuse, anorexia or use of other drugs that are able to damage the liver (see section 4 ) . Your doctor may do regular blood tests to monitor the condition of your liver . Tell your doctor if you have liver problems before starting treatment with Suboxone.
This product may cause a sudden drop in your blood pressure, make you feel dizzy if you stand up suddenly from a sitting or lying position.
Diagnosis of unrelated diseases
This medicine may mask pain symptoms that might help in the diagnosis of certain diseases . Remember to tell your doctor that you are taking this medicine.
Suboxone and other drugs
Some drugs may increase the effects of Suboxone and can sometimes cause very serious reactions. Do not take other medicines while taking Suboxone, without first consulting your doctor , especially :
Benzodiazepines ( used to treat anxiety or sleep disorders ) , such as diazepam , temazepam , alprazolam . Your doctor will prescribe the right dose. Taking incorrect dose benzodiazepines can cause death due to respiratory failure ( inability to breathe ) ;
Other drugs that can cause drowsiness , which are used to treat anxiety , insomnia , convulsions / seizures, pain . These types of medications will reduce your alertness and will hamper when driving or operating machinery. They can also cause depression of the central nervous system , which is very serious . Below is a list of examples of these types of drugs :
other drugs containing opioids such as methadone , certain analgesics , and agents for suppressing cough ;
antidepressants ( used for the treatment of depression) as isocarboxazid , phenelzine , selegiline , tranylcypromine and valproate can increase the effects of this drug;
sedative H1 receptor blockers (used to treat allergic reactions), such as diphenhydramine and hlorfenamin ;
barbiturates (used as sedatives or tranquilizers ) , such as phenobarbital , secobarbital ;
tranquilizers (used as a hypnotic or sedative ) and chloral hydrate ;
clonidine (used to treat high blood pressure ) can increase the effects of this drug;
antiretroviral agents (used for the treatment of AIDS ) , ritonavir , nelfinavir , indinavir, can increase the effects of this drug;
Some antifungal agents (used for the treatment of fungal infections), such as ketoconazole, itraconazole, certain antibiotics can prolong the effects of this drug;
Some medicines may reduce the effect of Suboxone. These include drugs used to treat epilepsy ( such as carbamazepine and phenytoin) , and drugs used to treat tuberculosis ( rifampicin) ;
Naltrexone may inhibit the therapeutic effects of Suboxone. If you are currently taking this medicine and then take and naltrexone , you may experience a sudden onset of intense and prolonged abstinence .
To get maximum benefit from treatment with Suboxone, you should tell your doctor about all the medicines you are taking , including alcohol, medicines containing alcohol, drugs, and any prescription medicines you are taking, but are not prescribed by your doctor.
Suboxone with food, drinks and alcohol
Alcohol may increase drowsiness and risk of respiratory failure if taken with Suboxone. Do not take Suboxone with alcohol . Do not swallow and do not consume food or any drinks until the tablet is dissolved.
Pregnancy and lactation
Risks with Suboxone in pregnant women are unknown. Inform your doctor if you are pregnant or plan to become pregnant. Your doctor will decide if your treatment should continue with alternative medicine.
When given during pregnancy, especially late pregnancy , medicines like Suboxone may cause withdrawal symptoms , including breathing problems in the newborn . They can occur a few days after birth.
Do not breast-feed while taking this medicine , as Suboxone passes into breast milk .
Ask for advice from your doctor or pharmacist before taking any medicine.
Driving and using machines
Suboxone may cause drowsiness. This can happen more often during the first few weeks of treatment when your dose is changed , but it can happen if you drink alcohol or take other sedatives , and when taking Suboxone. Do not drive, use tools or machinery or perform hazardous tasks until you know how this medication affects you .
Suboxone contains lactose
If you know your doctor that you have intolerance to some sugars , consult him before taking this medicine.
3 . How to take Suboxone
Treatment is prescribed and monitored by physicians who are experienced in the treatment of drug dependence.
Your doctor will determine the best dose for you. During your treatment your doctor may adjust the dose depending on how you respond .
Always take this medicine exactly as your told your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist.
The recommended starting dose for adults and adolescents over 15 years is one to two tablets of Suboxone 2 mg / 0,5 mg. Can apply an additional one to two tablets of Suboxone 2 mg / 0,5 mg on day one , depending on your needs.
Before taking the first dose of Suboxone, there should be clear signs of withdrawal . Evaluation of the physician for your readiness for treatment will determine the time of your first dose of Suboxone.
Initiation of treatment with Suboxone in heroin - If you have heroin or short-acting drug , you should take your first dose of Suboxone with signs of withdrawal , but no earlier than 6 hours after you last used time drugs;
Initiation of treatment with Suboxone in depending on methadone - If you've been on methadone or long-acting opioid , ideally methadone dose should be reduced to below 30 mg / day before treatment with Suboxone. The first dose of Suboxone should be taken in the presence of traces of abstinence , but not earlier than 24 hours after the last administration of methadone.
Approval of Suboxone
Take the dose once a day by placing the tablet under your tongue ;
Keep the tablets under the tongue until dissolved completely. This may take 5-10 minutes;
Do not chew or swallow the tablets because the medicine will not work and you may get withdrawal symptoms ;
Do not eat or drink until the tablets dissolve completely.
Dose adjustment and supportive care :
In the days after the start of treatment, your doctor may increase the dose of Suboxone, which take , depending on your needs. If you have the impression that the effect of Suboxone is too strong or too weak, contact your doctor or pharmacist. The maximum daily dose is 24 mg ( i.e., equal to three tablets Suboxone 8 mg / 2 mg, if the patient has stabilized in the treatment ) .
After some time of successful treatment can be understood by your doctor to reduce the dose gradually to a lower maintenance dose.
Discontinuation of treatment
Depending on your condition Suboxone dose reduction may continue under careful medical supervision eventually intake may be terminated .
In no way change the treatment and do not stop without the consent of your doctor .
If you take an overdose of Suboxone
If you or another person take too much of this medicine , you should go or be taken immediately to an emergency room or hospital for treatment as an overdose of Suboxone can cause serious and life-threatening breathing problems .
Symptoms of overdose may include drowsiness and lack of coordination with delayed reflexes , blurred vision and / or slurred speech . You may not be able to think clearly and can breathe much slower than usual for you.
If you forget to take Suboxone
Inform your doctor as soon as possible if you miss a dose.
If you stop taking Suboxone
In no way change the treatment and do not stop without the consent of your doctor. Stopping treatment suddenly can cause withdrawal symptoms .
If you have any further questions on the use of this product , ask your doctor or pharmacist.
How to remove the tablet from the blister
1 - Remove only one part of the blister pack , making it rip perforation .
2 - Starting from the end where the seal is raised , pull up the foil on the back to remove the tablet .
If the blister is damaged, discard the tablet.
4 . Possible side effects
Like all medicines , Suboxone can cause side effects, although not everybody gets them .
Tell your doctor immediately or seek emergency medical attention if you experience uncommon side effects , such as:
swelling of your face , lips, tongue or throat which may cause difficulty in swallowing or breathing , severe urticaria / hives . These may be symptoms of a life-threatening allergic reaction;
drowsiness and lack of coordination , blurred vision, slurred speech , inability to think clearly or correctly , or slow breathing under your normal level .
Tell your doctor immediately if you experience uncommon side effects , such as:
fatigue , itching, yellowing of the skin or eyes. These may be symptoms of liver damage ;
seeing or hearing things that do not currently exist ( hallucinations) .
Adverse effects reported with Suboxone
Very common side effects (may affect more than 1 user in 10 ):
insomnia , constipation , nausea , sweating , headache , withdrawal syndrome from drugs.
Common side effects (may affect up to 1 in 10 users ):
Weight loss, swelling (hands and feet ) , tiredness, drowsiness , anxiety , nervousness , tingling, depression, decreased sex drive, increased muscle tension , morbid thinking , increased lacrimation ( watery eyes ) or other breach of lacrimation , blurred vision, redness , increased blood pressure , migraines , runny nose, sore throat and painful swallowing, increased cough, upset stomach or other gastrointestinal discomfort, diarrhea , abnormal liver function , loss of appetite , flatulence , vomiting , rash, pruritus, urticaria , pain, joint pain, muscle pain , leg cramps (muscle spasms) , difficulty getting or maintaining an erection , changes in urine , abdominal pain , back pain , weakness , infection, chills , chest pain , fever, flu-like symptoms , feeling of malaise, accidental injury caused by the loss of alertness or coordination , fainting and dizziness , drop in blood pressure when standing up from a sitting or lying position.
Uncommon side effects (may affect up to 1 in 100 users ):
Swollen glands ( lymph nodes ), agitation , tremors , abnormal dreams , excessive muscle activity , depersonalization ( feeling you're not yourself) , drug dependence , amnesia (impaired memory) , loss of interest , excessive feeling of well-being , convulsions (seizures ) , impaired speech, pupil size , difficulty urinating , inflammation or infection of the eyes, rapid or slow heartbeat , low blood pressure , palpitations , myocardial infarction (heart attack) , chest tightness , shortness of breath , asthma , yawning , pain and mouth ulcers , discoloration , acne , skin nodules , hair loss , dry or peeling skin , inflammation of joints, urinary tract infection , abnormal blood tests , blood in urine , abnormal ejaculation , menstrual or vaginal problems , stones kidney , sensitivity to hot or cold , heat stroke , feeling hostility.
Rare side effects (may affect up to 1 in 1000 users) :
Slow or difficult breathing , liver damage , with or without jaundice , hallucinations, swelling of the face and throat or life-threatening allergic reactions.
Effects known ( from the available data can not be estimated ):
Sudden withdrawal syndrome caused by taking Suboxone too soon after the use of illegal drugs, drug withdrawal syndrome in neonates.
Improper use of the drug by injection may cause withdrawal symptoms , infections, other skin reactions and potentially serious liver problems ( see " Warnings and Precautions" ) .
If any of the side effects gets serious, or you notice other effects not listed in this leaflet , please tell your doctor or pharmacist.
Adverse event reporting
If you get any side effects , tell your doctor. This includes all listed in this leaflet . You can also report side effects directly through the national system of communication. As reported side effects , you can do your bit to get more information on the safety of this medicine.
You can also report adverse events directly to the holder of the marketing authorization via the email address on the website : QCHS.MI @ quintiles.com.
5 . How to store Suboxone
This medicinal product does not require any special storage conditions . Suboxone can, however, is a target for people who abuse drugs sold by prescription. Keep this medicine in a safe place to protect it from theft.
Keep out of reach of children and other household members . In case of accidental or intentional ingestion, buprenorphine can cause severe and potentially fatal respiratory failure in children and adults who do not suffer from addiction.
Keep the blister in a safe place. Never open the blister in advance. Do not take this medicine in front of children.
In case of accidental ingestion or suspected , it is necessary to immediately seek assistance from emergency medical care.
Not use Suboxone after the expiry date stated on the carton. The expiry date refers to the last day of that month.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required . These measures will help to protect the environment.
6 . Package Contents and more information
What does Suboxone
The active substances are buprenorphine and naloxone.
Each tablet of 2 mg / 0,5 mg comprises 2 mg buprenorphine (as hydrochloride ) 0,5 mg and naloxone (as hydrochloride dihydrate) .
The other ingredients are lactose monohydrate, mannitol , corn starch , povidone K30, anhydrous citric acid , sodium citrate, magnesium stearate, acesulfame potassium and natural flavors of lemon and lime .
Suboxone looks like and contents of the pack
Suboxone sublingual tablets 2 mg / 0,5 mg are white hexagonal biconvex tablets 6,5 mm embossed logo in the form of a sword on one side and "N2" on the other side . Available in packs of 7 and 28 tablets.
Not all pack sizes may be marketed.