Package Insert: Information for the User

Suboxone 8 mg/2 mg Sublingual Tablets

buprenorphine/naloxone

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.

• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Suboxone is used to treat opioid dependence (narcotics), such as heroin or morphine, in individuals who have given their consent to be treated for their addiction. Suboxone is used inadults and older adolescents over 15 years oldwho are also receiving medical, social, andpsychological support.

Do not take Suboxone

• if you are allergic to buprenorphine, naloxone, or any of the other ingredients in this medication (listed in section 6);

• if you have severe respiratory problems;

• if you have severe liver problems;
• if you are intoxicated with alcohol or have symptoms such as tremors, sweating, anxiety, confusion, or hallucinations caused by alcohol;
• if you are taking naltrexone or nalmefene for the treatment of alcohol or opioid dependence.

Warnings and precautions

Consult your doctor before starting Suboxone if you have:

• asthma or other respiratory problems;
• liver problems such as hepatitis;
• low blood pressure;
• a head injury or recent brain disease;
• urinary problems (especially associated with an enlarged prostate in men);
• kidney disease;
• thyroid problems;
• adrenal gland disorders (e.g., Addison's disease);
• depression or other conditions treated with antidepressants. The use of these medications with Suboxone may cause serotonin syndrome, a potentially life-threatening condition (see "Other medications and Suboxone").

Important considerations:

• In case of accidental ingestion or suspected ingestion, contact emergency services immediately.

• Additional monitoring

If you are over 65 years old, your doctor may monitor you more closely.

• Abuse and misuse

This medication may be a target for people who abuse prescription medications and should be kept in a safe place to protect it from theft (see section 5).Do not give this medication to anyone else.It may cause death or other harm.

• Respiratory problems

Some people have died from respiratory failure (inability to breathe) because they have used buprenorphine improperly or taken it with other central nervous system depressants, such as alcohol, benzodiazepines (sedatives), or other opioids.

This medication may cause severe respiratory depression (difficulty breathing), possibly fatal, in children and non-dependent individuals if ingested accidentally or intentionally.

• Dependence

This medication may cause dependence.

• Withdrawal symptoms

This medication may cause opioid withdrawal symptoms if taken too soon after using opioids. Allow at least 6 hours after using a short-acting opioid (e.g., morphine, heroin) or at least 24 hours after using a long-acting opioid, such as methadone.

This medication may also cause withdrawal symptoms if stopped suddenly. See section 3 "If treatment is interrupted."

• Liver damage

Cases of liver damage have been reported after taking Suboxone, especially when the medication is used improperly. It may also be caused by viral infections (e.g., chronic hepatitis C), alcohol abuse, anorexia, or the use of other medications that can damage the liver (see section 4).Your doctor may perform frequent blood tests to monitor your liver function.Inform your doctor if you have any liver problems before starting treatment with Suboxone.

• Blood pressure

This medication may cause a sudden drop in blood pressure, making you feel dizzy if you stand up too quickly after sitting or lying down.

• Diagnosis of unrelated medical conditions

This medication may mask pain symptoms that could help diagnose certain conditions. Inform your doctor that you are taking this medication.

Children and adolescents

Do not give this medication to children under 15 years old.If you are between 15 and 18 years old, your doctor may monitor you more closely during treatment due to a lack of data in this age group.

Other medications and Suboxone

Inform your doctor if you are taking, have taken recently, or may need to take any other medication.

Some medications may increase the adverse effects of Suboxone, and may be severe. Do not take other medications at the same time as Suboxone without consulting your doctor first, especially:

• sedatives (used to treat anxiety or sleep disorders) such as diazepam, temazepam, or alprazolam. The concomitant use of Suboxone and sedatives such as benzodiazepines or related medications increases the risk of drowsiness, difficulty breathing (respiratory depression), and coma, and may be potentially fatal. Therefore, concomitant use should only be considered when other treatment options are not possible. However, if your doctor prescribes Suboxone with sedatives, your doctor should limit the dose and duration of concomitant treatment. Inform your doctor about all sedatives you take and follow your doctor's dosage recommendation strictly. It may be helpful to inform your friends or family to be aware of the signs and symptoms mentioned above. Contact your doctor if you experience these symptoms.

• Other medications that may cause drowsiness and are used to treat conditions such as anxiety, insomnia, seizures/epileptic crises, or pain.

• other medications that contain opioids such as methadone, some analgesics, or antitussives;
• antidepressants (used to treat depression) such as isocarboxazid, phenelzine, selegiline, tranylcypromine, and valproate may potentiate the effects of this medication;
• sedating H1 receptor antagonists (used to treat allergic reactions) such as diphenhydramine and chlorpheniramine;
• barbiturates (used to induce sleep or sedation) such as phenobarbital or secobarbital;
• sedatives (used to induce sleep or sedation) such as chloral hydrate.

• Antidepressantssuch as moclobemide, tranylcypromine, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, duloxetine, venlafaxine, amitriptyline, doxepin, or trimipramine. These medications may interact with Suboxone and you may experience symptoms such as involuntary muscle contractions, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, and a body temperature above 38°C. Contact your doctor if you experience these symptoms.

• The clonidine (used to treat high blood pressure) may prolong the effects of this medication.
• Antiretrovirals (used to treat HIV) such as ritonavir, nelfinavir, or indinavir may potentiate the effects of this medication.
• Determined antifungals (used to treat fungal infections) such as ketoconazole, itraconazole, or certain antibiotics may prolong the effects of this medication.

• Some medications may decrease the effect of Suboxone. These include medications used to treat epilepsy (carbamazepine and phenytoin) and medications used to treat tuberculosis (rifampicin).
• Naltrexone and nalmefene (medications used to treat addictive disorders) may block the therapeutic effects of Suboxone. Do not take them at the same time as Suboxone treatment, as you may experience a sudden onset of prolonged and intense withdrawal symptoms.

Suboxone with food, drinks, and alcohol

Do not drink alcoholwhile receiving treatment with this medication. Alcohol mayincrease drowsiness and the risk of respiratory failure if taken with Suboxone. Do not swallow or consume food or drinks until the tablet has completely dissolved.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication. The risks of using Suboxone in pregnant women are unknown. Your doctor will decide whether you should continue treatment with another medication.

When taken during pregnancy, especially in the last months, medications like Suboxone may cause withdrawal symptoms in the newborn, including respiratory problems, several days after birth.

Do not breastfeed while taking this medication, as buprenorphine is excreted in breast milk.

Driving and operating machinery

Do not drive or ride a bike, do not use tools or machines, or engage in hazardous activitiesuntil you know how this medication affects you. Suboxone may cause drowsiness, dizziness, or altered thinking. This may occur more frequently in the first weeks of treatment, when the dose is changing, but it may also occur if you drink alcohol or take other sedatives at the same time as taking Suboxone.

Suboxone contains lactose and sodium.

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free."

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Medications are prescribed and supervised by experienced doctors in the treatment of addiction.

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

Starting treatment

The recommended initial dose in adults and adolescents over 15 years old is usually two sublingual tablets of Suboxone 2 mg/0.5 mg.

This dose can be repeated twice more on day 1, as needed.

Before taking your first dose of Suboxone, you should know the clear symptoms of withdrawal. Your doctor will tell you when to take your first dose.

• Starting treatment with Suboxone if you haveheroin dependence

If you have heroin or short-acting opioid dependence, the first dose should be taken when withdrawal symptoms appear,at least 6 hours after the last time you used opioids.

• Starting treatment with Suboxone if you havemethadone dependence

If you have been taking methadone or a long-acting opioid, it is best to reduce the methadone dose to less than 30 mg/day before starting treatment with Suboxone. The first dose of Suboxone should be taken when withdrawal symptoms appear andat least 24 hours after the last time you used methadone.

How to take Suboxone

• Take the dose once a day, placing the tablets under the tongue.

• Keep the tablets under the tongue until they havecompletely dissolved. This may take between 5 and 10 minutes.

• Do not chew or swallow the tablets, as the medication will not work and may cause withdrawal symptoms.

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

How to remove the tablet from the blister

If the blister is damaged, discard the tablet.

Dose adjustment and maintenance treatment:

During the days following the start of treatment, your doctor may increase your Suboxone dose as needed. If you believe the effect of Suboxone is too intense or too weak, inform your doctor or pharmacist.The maximum daily dose is 24 mg of buprenorphine.

After a satisfactory treatment period, you may agree with your doctor to gradually reduce the dose to a lower maintenance dose.

Stopping treatment

Depending on your condition, the Suboxone dose may continue to decrease under close medical supervision until it can be stopped.

Do not change the treatment in any way or stop it without the authorization of the doctor treating you.

If you take more Suboxone than you should

If you, or someone else, take an excessive amount of this medication, you should go immediately to the Emergency Room or a hospital to receive treatment, as aSuboxone overdosecan cause severe and potentially fatal respiratory problems.

Overdose symptoms may include a feeling of drowsiness and discoordination with slow reflexes, blurry vision, and/or difficulty speaking. You may not be able to think clearly and may breathe much slower than normal for you.

If you forget to take Suboxone

If you forget to take a dose, inform your doctor as soon as possible.

If you stop treatment with Suboxone

Do not change the treatment in any way or stop it without the authorization of the doctor treating you.Sudden treatment interruption may cause withdrawal symptoms.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Inform your doctor or seek urgent medical attentionif you experience side effects such as:

• • Swelling of the face, lips, tongue, or throat, which may cause difficulty swallowing or breathing; intense urticarial/hives. These may be signs of a potentially life-threatening allergic reaction.
• Drowsiness and disorientation, blurred vision, difficulty speaking, inability to think clearly, or breathing that is much slower than normal for you.

Also, inform your doctorif you experience side effects such as:

• • Intense fatigue, yellowing skin or eyes with itching. These may be signs of liver damage.
• Seeing or hearing things that do not actually exist (hallucinations).

Side effects reported with Suboxone

Abuse of this medicine by injection may cause withdrawal symptoms, infections, other skin reactions, and potentially severe liver problems (see "Warnings and precautions").

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is not listed in this leaflet. You can also report them directly through thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep this medication out of the sight and reach of children and other family members.

Do not use this medication after the expiration date that appears on the box. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions. However, Suboxone may be a target for individuals who abuse prescription medications. Keep this medication in a safe place to protect it from theft.

Store the blister pack safely.

Never open the blister pack before the time indicated.

Do not take this medication in front of children.

In case of accidental ingestion or suspected ingestion, contact an emergency unit immediately.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

Composition of Suboxone

• The active principles are buprenorphine and naloxone.

Each sublingual tablet of 8 mg/2 mg contains 8 mg of buprenorphine (as hydrochloride) and 2 mg of naloxone (as dihydrate hydrochloride).

• The other components are lactose monohydrate, mannitol, cornstarch, povidone K30, anhydrous citric acid, sodium citrate, magnesium stearate, potassium acesulfame, and natural lemon and lime flavor.

Appearance of the product and contents of the package

Suboxone 8 mg/2 mg sublingual tablets are white, hexagonal, and biconvex tablets

Packaged in containers of 7 and 28 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Indivior Europe Limited

27 Windsor Place

Dublin 2

Ireland

Responsible for manufacturing

Reckitt Benckiser Healthcare (UK) Ltd,

Dansom Lane,

Hull,

East Yorkshire HU8 7DS,

United Kingdom

Or

Indivior Europe Limited

27 Windsor Place

Dublin 2

Ireland

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Last review date of this leaflet:

The detailed information about this medication is available on the website of the European Medicines Agency: http://www.ema.europa.eu/.