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AstraZeneca

Suboxone
buprenorphine, naloxone

Package leaflet: Information for the user


Suboxone 2 mg/0.5 mg sublingual tablets Suboxone 8 mg/2 mg sublingual tablets Suboxone 16 mg/4 mg sublingual tablets


buprenorphine / naloxone


Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.



Do not consume any food or drink until the tablets have completely dissolved.

How to remove the tablet from the blister



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1 - Do not push the tablet through the foil. 1


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    1. 2 - Remove just one section from the blister pack, tearing it along the perforated line.


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    2. 3 – Starting from the edge where the seal is lifted, pull back the foil on the back to remove the tablet


      If the blister is damaged, discard the tablet


      Dose adjustment and maintenance therapy:


      During the days after you start treatment, your doctor may increase the dose of Suboxone you take according to your needs. If you think that the effect of Suboxone is too strong or too weak, talk to your doctor or pharmacist. The maximum daily dose is 24 mg buprenorphine.


      After a time of successful treatment, you may agree with your doctor to reduce the dose gradually to a lower maintenance dose.


      Stopping treatment


      Depending on your condition, the dose of Suboxone may continue to be reduced under careful medical supervision, until eventually it may be stopped.


      Do not change the treatment in any way or stop treatment without the agreement of the doctor who is treating you.


      If you take more Suboxone than you should

      If you or someone else takes too much of this medicine, you must go or be taken immediately to an emergency centre or hospital for treatment as overdose with Suboxone may cause serious and life- threatening breathing problems.

      Symptoms of overdose may include feeling sleepy and uncoordinated with slowed reflexes, blurred vision, and/or slurred speech. You may be unable to think clearly, and may breathe much slower than is normal for you.


      If you forget to take Suboxone

      Tell your doctor as soon as possible if you miss a dose.


      If you stop taking Suboxone

      Do not change the treatment in any way or stop treatment without the agreement of the doctor who is treating you. Stopping treatment suddenly may cause withdrawal symptoms.

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


  1. Possible side effects


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


    Tell your doctor immediately or seek urgent medical attention if you experience side effects, such as:

    • swelling of the face, lips, tongue or throat which may cause difficulty in swallowing or breathing, severe hives/nettle rash. These may be signs of a life-threatening allergic reaction.

    • feeling sleepy and uncoordinated, have blurred vision, have slurred speech, cannot think well or clearly, or your breathing gets much slower than is normal for you.


    Also tell your doctor immediately if you experience side effects such as:

    • severe tiredness, itching with yellowing of skin or eyes. These may be symptoms of liver damage.

    • seeing or hearing things that are not there (hallucinations).


    Side effects reported with Suboxone


    Very common side effects (may affect more than one in 10 people):

    Insomnia (inability to sleep), constipation, nausea, excessive sweating, headache, drug withdrawal syndrome

    Common side effects (may affect up to 1 in 10 people):

    Weight loss, swelling of the hands and feet, drowsiness, anxiety, nervousness, tingling, depression, decreased sexual drive, increase in muscle tension, abnormal thinking, increased tearing (watering eyes) or other tearing disorders, blurred vision, flushing, increased blood pressure, migraines, runny nose, sore throat and painful swallowing, increased cough, upset stomach or other stomach discomfort, diarrhoea, abnormal liver function, flatulence, vomiting, rash, itching, hives, pain, joint pain, muscle pain, leg cramps (muscle spasm), difficulty in getting or keeping an erection, urine abnormality, abdominal pain, back pain, weakness, infection, chills, chest pain, fever, flu-like symptoms, feeling of general discomfort, accidental injury caused by loss of alertness or co-ordination, faintness and dizziness.

    Uncommon side effects (may affect up to 1 in 100 people):

    Swollen glands (lymph nodes), agitation, tremor, abnormal dream, excessive muscle activity, depersonalisation (not feeling like yourself), medicine dependence, amnesia (memory disturbance), loss of interest, exaggerated feeling of wellbeing, convulsion (fits), speech disorder, small pupil size, difficulty urinating, eye inflammation or infection, rapid or slow heartbeat, low blood pressure, palpitations, heart attack, chest tightness, shortness of breath, asthma, yawning, pain and sores in mouth, tongue discolouration, acne, skin nodule, hair loss, dry or scaling skin, inflammation of joints, urinary tract infection, abnormal blood tests, blood in urine, abnormal ejaculation, menstrual or vaginal problems, kidney stone, protein in your urine, painful or difficult urination, sensitivity to heat or cold, heat stroke, loss of appetite, feelings of hostility.

    Not known (frequency cannot be estimated from the available data):

    Sudden withdrawal syndrome caused by taking Suboxone too soon after use of illicit opioids, drug withdrawal syndrome in new-born babies, slow or difficult breathing, liver injury with or without jaundice, hallucinations, swelling of face and throat or life threatening allergic reactions, drop in blood pressure on changing position from sitting or lying down to standing.


    Misusing this medicine by injecting it can cause withdrawal symptoms, infections, other skin reactions and potentially serious liver problems (see Warnings and precautions).

    Reporting of side effects

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    If you get any side-effects, talk to your doctor or pharmacist. This includes any possible side-effects not listed in this leaflet. You can also report side-effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.


  2. How to store Suboxone


    Keep this medicine out of the sight and reach of children and other household members.


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


    This medicine does not require any special storage conditions. However, Suboxone can be a target for people who abuse prescription medicine. Keep this medicine in a safe place to protect it from theft.


    Store the blister safely.

    Never open the blister in advance.

    Do not take this medicine in front of children.

    An emergency unit should be contacted immediately in case of accidental ingestion or suspicion of ingestion.


    Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.


  3. Content of the pack and other information What Suboxone contains


What Suboxone looks like and contents of the pack


Suboxone 2 mg/0.5 mg sublingual tablets are white hexagonal biconvex tablets of 6.5 mm with “N2” debossed on one side.

Suboxone 8 mg/2 mg sublingual tablets are white hexagonal biconvex tablets of 11 mm with “N8” debossed on one side.

Suboxone 16 mg/4 mg sublingual tablets are white round biconvex tablets of 10.5 mm with “N16”

debossed on one side.


Packed in packs of 7 and 28 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer


Indivior Europe Limited 27 Windsor Place

Dublin 2

D02 DK44

Ireland


For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:


België/Belgique/Belgien Indivior Europe Limited Tél/Tel: 0800 780 41

e-mail: PatientSafetyRow@indivior.com

Lietuva

Indivior Europe Limited Tel: 88003079

e-mail: PatientSafetyRoW@indivior.com


България

Indivior Europe Limited Teл.: 00800 110 4104

e-mail: PatientSafetyRoW@indivior.com

Luxembourg/Luxemburg Indivior Europe Limited Tél/Tel: 800 245 43

e-mail: PatientSafetyRow@indivior.com


Česká republika Indivior Europe Limited Tel: 800 143 737

e-mail: PatientSafetyRoW@indivior.com

Magyarország

Indivior Europe Limited Tel.: 6800 19301

e-mail: PatientSafetyRoW@indivior.com


Danmark

Indivior Europe Limited Tlf: 80826653

e-mail: PatientSafetyRoW@indivior.com

Malta

Indivior Europe Limited Tel: 80062185

e-mail: PatientSafetyRoW@indivior.com


Deutschland

Indivior Europe Limited Tel: 0 800 181 3799

e-mail: PatientSafetyRoW@indivior.com

Nederland

Indivior Europe Limited Tel: 0800 022 87 83

e-mail: PatientSafetyRow@indivior.com


Eesti

Indivior Europe Limited Tel: 8000041004

e-mail: PatientSafetyRoW@indivior.com

Norge

Indivior Europe Limited Tlf: 80016773

e-mail: PatientSafetyRoW@indivior.com


Ελλάδα

Indivior Europe Limited Τηλ: 800 206 281 901

e-mail: PatientSafetyRoW@indivior.com

Österreich

Indivior Europe Limited Tel: 800 296551

e-mail: PatientSafetyRoW@indivior.com


España

Indivior Europe Limited Tel: 900 994 121

e-mail: PatientSafetyRoW@indivior.com

Polska

Indivior Europe Limited Tel.: 0800 4111237

e-mail: PatientSafetyRoW@indivior.com


France

Indivior Europe Limited

Tél: 0800 909 972

e-mail: PatientSafetyFrance@indivior.com

Portugal

Indivior Europe Limited Tel: 800 841 042

e-mail: PatientSafetyRoW@indivior.com

Hrvatska

Indivior Europe Limited Tel: 0800 222 899

e-mail: PatientSafetyRoW@indivior.com

România

Indivior Europe Limited Tel: 800 477 029

e-mail: PatientSafetyRoW@indivior.com


Ireland

Indivior Europe Limited Tel: 1800554156

e-mail: PatientSafetyRoW@indivior.com

Slovenija

Indivior Europe Limited Tel: 080080715

e-mail: PatientSafetyRoW@indivior.com


Ísland

Indivior Europe Limited Sími: 8009875

Netfang: PatientSafetyRoW@indivior.com

Slovenská republika Indivior Europe Limited Tel: 800110286

e-mail: PatientSafetyRoW@indivior.com


Italia

Indivior Europe Limited Tel: 800 789 822

e-mail: PatientSafetyRoW@indivior.com

Suomi/Finland

Indivior Europe Limited Puh/Tel: 0800417489

e-mail: PatientSafetyRoW@indivior.com


Κύπρος

Indivior Europe Limited Τηλ: 80091515

e-mail: PatientSafetyRoW@indivior.com

Sverige

Indivior Europe Limited Tel: 020791680

e-mail: PatientSafetyRoW@indivior.com


Latvija

Indivior Europe Limited Tel: 800 05612

e-mail: PatientSafetyRoW@indivior.com

United Kingdom (Northern Ireland)

Indivior Europe Limited Tel: 0808 234 9243

e-mail: PatientSafetyRoW@indivior.com


This leaflet was last revised in