Can you quit Suboxone

Suboxone 8 mg / 2 mg sublingual tablets

RB Pharmaceuticals

Addictive drugPsychotropic
NoNo
Pharmacological groupMeans for the treatment of addictions

All information

What is it and what is it used for?

Suboxone is used to treat addiction to opioids (narcotics), e.g. B. heroin or morphine, determined in drug addicts who have consented to addiction treatment. Suboxone is intended for the treatment of adults and adolescents over 15 years of age who receive simultaneous medical, social and psychotherapeutic care.

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What do you need to consider before use?

Suboxone must not be used
  • if you are allergic (hypersensitive) to buprenorphine, naloxone (the active substances in Suboxone) or any of the other ingredients of this medicine.
  • if you have severe breathing problems.
  • if you have severe liver problems.
  • if you are heavily drunk or have tremors, profuse sweating, anxiety, confusion or hallucinations caused by alcohol (Delirium tremens).
Take special care when using Suboxone
Improper use and abuse
Buprenorphine may be of interest to those who abuse prescription drugs. It should therefore be kept safe from theft. Do not give this medicine to anyone else. It can lead to death in other people or otherwise harm them.
Breathing problems
Some people died as a result of respiratory failure (respiratory failure) because they were abused by buprenorphine or because they were taking buprenorphine with other substances that depress the central nervous system, such as: B. have used alcohol, benzodiazepines (tranquilizers), or other opioids.
Addiction
This medicine can lead to dependence.
Withdrawal symptoms
This medicine can cause withdrawal symptoms if you take it earlier than six hours after using a short-acting opioid (e.g. morphine, heroin) or earlier than 24 hours after using a long-acting opioid, e.g. B. methadone apply.

Suboxone can cause withdrawal symptoms even if you suddenly stop taking it.

Liver damage
Cases of liver damage have been reported, particularly related to drug abuse. This damage could be due to viral infections (chronic hepatitis C), alcohol abuse, anorexia or drugs (e.g. antiretroviral nucleoside analogues (used to treat the HIV virus (human immunodeficiency virus, AIDS pathogen)); acetylsalicylic acid (substance contained in amiodarone (used to treat irregular heartbeat); rifampicin (used to treat tuberculosis), valproate (used to treat seizures, depression, migraine headaches and schizophrenia).

If you experience symptoms such as severe tiredness or itching, or if your skin or eyes are yellow, tell your doctor immediately so that you can receive appropriate treatment.

Sleepiness
This medicine can make you sleepy, which could be made worse by alcohol or the use of anxiety relievers (see? Using other medicines?).
Blood pressure
The use of this medicine may cause a sudden drop in blood pressure which may cause dizziness if you suddenly get up from sitting or lying down.
Effects on symptoms of non-addiction related disorders
This medicine can mask symptoms of pain that may be useful in diagnosing certain conditions. Do not forget to tell your doctor if you are using this medicine.

Let your doctor know if

  • you have bronchial asthma or other breathing problems.
  • you have liver disease.
  • You have recently had a head injury or illness that increases pressure on the brain.
  • You have low blood pressure.
  • You as a man suffer from urinary tract disorders (particularly those associated with enlarged prostate).
  • you have kidney disease.
Using Suboxone with other medicines
Other medicines and Suboxone could increase the side effects of buprenorphine. The use of the following medicines should be carefully monitored:
  • Benzodiazepines (e.g. diazepam, temazepam, alprazolam), which are used to treat anxiety or sleep disorders. If your doctor prescribes benzodiazepines for you, do not use more than the prescribed dose. Using this medicine with benzodiazepines can result in death from respiratory failure.
  • Tranquilizers used as sleeping aids or sedatives (e.g., chloral hydrate, hydroxyzine, phenobarbital, secobarbital, amobarbital, and pentobarbital) can increase the effects of buprenorphine on reducing breathing and alertness.
  • Medicines used to treat anxiety (e.g. benzodiazepines, phenobarbital, buspirone, pregbaline) may increase the effects of buprenorphine on decreasing breathing and alertness.
  • Medicines used to treat depression (e.g. isocarboxazid, phenelzine, selegelin, tranylcypromine, valproate) may increase the effects of buprenorphine.
  • Clonidine, used to treat high blood pressure, can increase the effects of buprenorphine.
  • Antiretroviral medicines used to treat AIDS (e.g. ritonavir, nelfinavir, indinavir) can increase the effects of buprenorphine.
  • Certain medicines used to treat fungal infections (e.g. ketoconazole and itraconazole) can reduce the effects of buprenorphine.
  • Certain medicines can also affect your liver, but the effects related to Suboxone are not known. This concerns inter alia. Medicines used to treat epilepsy, e.g. B. phenobarbital, carbamazepine or phenytoin, and a medicine used to treat tuberculosis (rifampicin).

To get the maximum benefit from treatment with Suboxone, you must tell your doctor about all medicines you are taking, including alcohol, medicines containing alcohol, street drugs, and any prescription medicines that you are taking but are not prescribed by your doctor.

Using Suboxone with food and drink
Do not use Suboxone with alcoholic beverages as alcohol could increase the sleepiness caused by Suboxone. Do not consume food and drink until the tablet has completely dissolved.
pregnancy and breast feeding period
Ask your doctor or pharmacist for advice before taking any medicine.

The risks of taking Suboxone during pregnancy are unknown. Tell your doctor if you are pregnant or plan to become pregnant. Your doctor will decide whether your treatment should be continued with alternative medication.

Because this medicine can pass into breast milk and cause side effects in the breast-fed infant, you should not breast-feed while taking Suboxone.

Driving and using machines
Suboxone can cause sleepiness. This may happen more often in the first few weeks of treatment when your dose is adjusted, but it can also happen if you drink alcohol or use other sedatives while taking Suboxone. If you feel tired, do not drive or use machines, do not use any tools or machines, or engage in dangerous activities until you know exactly how this medicine affects you.
Important information about certain of the ingredients of Suboxone
Suboxone contains lactose. If your doctor has told you that you have an intolerance to certain sugars, talk to your doctor before using this medicine.

How is it used?

The use of the drug is prescribed and supervised by doctors who are experienced in the treatment of drug addiction.

Your doctor will determine the most suitable dose for you. During your treatment, the doctor may adjust the dose based on your response.

Initiation of treatment
The recommended starting dose for adults and adolescents over 15 years of age is one or two Suboxone tablets 2 mg / 0.5 mg. Depending on your needs, one or two Suboxone tablets 2 mg / 0.5 mg can also be administered on the first day.

There must be clear signs of withdrawal before taking the first dose of Suboxone. When your doctor determines, based on your condition, that it is a good time to start treatment, you will be given your first dose of Suboxone.

Start treatment with Suboxone if you are addicted to heroin
If you are addicted to heroin or a short-acting opioid, you should take your dose of Suboxone at the first signs of withdrawal, but no earlier than 6 hours after your last opioid use.
Start treatment with Suboxone if you are dependent on methadone.
If you have used methadone, the daily dose should be reduced to 30 mg / day before starting Suboxone therapy. The first dose of Suboxone should be taken at the first symptoms of withdrawal, but no earlier than 24 hours after you last used methadone.

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Dose adjustment and maintenance therapy:

After starting therapy, the doctor can adjust your dose of Suboxone to your needs over the course of the following days. The maximum daily dose is 24 mg.

Duration of treatment

The duration of treatment is determined individually by you and your doctor.

After a period of successful treatment, you may agree with your doctor to gradually reduce the dose to a lower maintenance dose. Depending on your condition, the dose of Suboxone can be further reduced under careful medical supervision until the therapy can finally be stopped.

You must not change or discontinue treatment in any way without the prior consent of your treating doctor.

The effectiveness of this treatment depends on

  • the dose.
  • the integration into a corresponding medical, psychotherapeutic and social framework program.

If you have the impression that the effect of Suboxone is too strong or too weak, please talk to your doctor or pharmacist.

type of application
Take the dose once a day by placing the tablets under your tongue. From there, buprenorphine passes into your bloodstream. If you swallow the tablet, it will not work. Hold the tablets under your tongue until they are completely dissolved. This can take 5-10 minutes. Do not chew, swallow, or eat any food or drink until the tablets are completely dissolved.
If you use more Suboxone than you should
Suboxone can cause severe and life-threatening breathing problems. Symptoms of an overdose can include: B. Feeling light-headed and having trouble coordinating with blurred vision and / or speech disorders. Your breathing can be significantly slower than you normally would.

In the event of an overdose of Suboxone, you must immediately go to or be taken to an emergency room or clinic for treatment.

Tell your doctor or pharmacist immediately.

If you forget to use Suboxone
Please contact your doctor.
If you stop using Suboxone
You must not change or discontinue treatment in any way without the prior consent of your treating doctor. Suddenly stopping treatment can lead to withdrawal symptoms.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

What are the possible side effects?

Like all medicines, Suboxone can cause side effects, although not everybody gets them.

The most common side effects are constipation and symptoms generally associated with drug withdrawal (i.e. insomnia (sleeplessness), headache, nausea, and sweating).

Tell your doctor immediately or get emergency medical care immediately if you experience the following rare side effects:

  1. Swelling of the face, lips, tongue or throat which may make it difficult to swallow or breathe, severe rash / hives. These could be signs of a

life threatening allergic reaction.

o Feeling light-headed and incoordination, blurred vision, language problems, or your breathing is noticeably slower than you normally would.

Also tell your doctor straight away if you have any of the following rare side effects:

  1. severe tiredness or itching with yellowing of the skin or eyes. These could be symptoms of liver damage.

o When you see or hear things that are not really there (hallucinations).

The frequencies of the possible side effects listed below are defined according to the following principle:

o very common (affects more than 1 in 10 people) o common (affects 1 to 10 in 100 people)

o uncommon (affects 1 to 10 users in 1,000) o rare (affects 1 to 10 users in 10,000)

o very rare (affects less than 1 in 10,000 people)

o not known (frequency cannot be estimated from the available data).

Very common side effects:
Insomnia (sleeplessness), constipation, nausea, sweating, headache, drug withdrawal syndrome
Frequent side effects:
Weight loss, swelling (of the hands and feet), tiredness, sleepiness, anxiety, nervousness, tingling, depression, decreased libido, increased muscle tension, abnormal thinking, lacrimation disorder, blurred vision, feeling hot, increased blood pressure, migraines, runny nose, sore throat and Pain when swallowing, increased cough, upset stomach, diarrhea, liver dysfunction, loss of appetite, flatulence, vomiting, rash, itching, hives, pain, joint pain, muscle pain, leg cramps (muscle spasm), difficulty getting or keeping an erection, abnormality urine, abdominal pain, back pain, weakness, infection, chills, chest pain, fever, flu syndrome, general malaise, accidental injuries, fainting and dizziness, drop in blood pressure when getting up from sitting or lying down.
Uncommon side effects:
Swelling of the glands (lymph nodes), agitation, tremors (tremors), abnormal dreams, excessive muscle activity, depersonalization (feeling of alienation), drug addiction, amnesia (memory disorders), loss of interest, excessive feeling of well-being, convulsion (seizures), speech disorders, small pupils, problems urinating, eye inflammation or infection, fast or slow heartbeat, low blood pressure, palpitations, myocardial infarction (heart attack), chest tightness, shortness of breath, asthma, yawning, pain and mouth sores, tongue discoloration, acne, skin lumps, hair loss, dry or flaky skin Inflammation of the joints, urinary tract infection, abnormal blood tests, blood in the urine, abnormal ejaculation, menstrual or vaginal problems, kidney stones, sensitivity to heat or cold, allergic reactions, hostility.
Rare side effects
Slowed breathing or shortness of breath, liver injury with or without jaundice, hallucinations, swelling of the face and neck, or life-threatening allergic reactions.
Not known
Sudden withdrawal syndrome as a result of using Suboxone too early after using illegal opioids, spontaneous abortion, drug withdrawal syndrome in newborns.

Misuse of this medicine by injection may lead to withdrawal symptoms, infections, other skin reactions and potentially serious liver problems (see section? Take special care with Suboxone?).

If one of the listed side effects gets serious, or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.

How should it be stored?

Store drug out of reach of children.

Do not use Suboxone after the expiry date which is stated on the carton. The expiry date refers to the last day of the month.

This medicinal product does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer need. This measure helps to protect the environment.

additional Information

What Suboxone contains
  • The active ingredients are buprenorphine and naloxone. One sublingual tablet Suboxone 8 mg / 2 mg contains 8 mg buprenorphine (as hydrochloride) and 2 mg naloxone (as hydrochloride dihydrate).
  • The other ingredients are lactose monohydrate, mannitol (Ph.Eur.), Corn starch, povidone K30, citric acid, sodium citrate, magnesium stearate (Ph.Eur.), Acesulfame potassium and natural lemon and lime flavoring.
What Suboxone looks like and contents of the pack
Suboxone sublingual tablets 8 mg / 2 mg are white, hexagonal, biconvex, 6.5 mm tablets with an embossed sword logo on one side and the debossed? N8? (8 mg) on ​​the other hand.

Packed in packs of 7 or 28 tablets

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Pharmaceutic entrepreneur:

RB Pharmaceuticals Limited

103-105 Bath Road

Slough

Berkshire SL1 3UH

United Kingdom

Tel. + 800 270 81 901

Manufacturer:

Reckitt Benckiser Healthcare (UK) Ltd,

Dansom Lane,

Hull,

East Yorkshire HU8 7DS,

United Kingdom.

If you would like further information about the medicinal product, please contact the pharmaceutical company.

België / Belgique / Belgium, ????????, Ceská republika, Danmark, Germany, Eesti, ???? da, España, France, Ireland, Ísland, Italia, ?? p ???, Latvija, Lietuva , Luxembourg / Luxemburg, Magyarország, Malta, Nederland, Norge, Austria, Polska, Portugal, România, Slovenija, Slovenská republika, Suomi / Finland, Sverige, United Kingdom.

RB Pharmaceuticals Limited

Tel. +800 270 81 901(This telephone number is valid for the entire European area.)

This leaflet was last approved in{MM / YYYY}

Detailed information on this medicine is available on the website of the European Medicines Agency http://www.ema.europa.eu/available.

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