SUBOXONE 2 mg/0.5 mg SUBLINGUAL TABLETS

2. What you need to know before you take Suboxone

Do not take Suboxone

• if you are allergic to buprenorphine, naloxone or any of the other ingredients of this medicine (listed in section 6);
• if you have severe respiratory problems;
• if you have severe liver problems;
• if you are suffering from alcoholic intoxicationor if you have tremors, sweating, anxiety, confusion or hallucinations caused by alcohol;
• if you are taking naltrexoneor nalmefenefor the treatment of alcohol or opioid dependence.

Warnings and precautions

Tell your doctor before you start taking Suboxone if you have:

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

Important things to bear in mind:

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

• Additional monitoring

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

• Misuse and abuse

This medicine may be targeted by people who abuse prescription medicines and should be kept in a safe place to protect it from theft (see section 5). Do not give this medicine to anyone else. It may cause them to die or have other serious problems.

• Respiratory problems

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

This medicine can cause severe respiratory depression (difficulty breathing) that can be life-threatening in children and non-dependent persons if they ingest it accidentally or intentionally.

• Sleep-related breathing disorders

Suboxone may cause sleep-related breathing disorders such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). Symptoms may include pauses in breathing during sleep, nighttime awakenings due to difficulty breathing, difficulty maintaining sleep, or excessive daytime sleepiness. Contact your doctor if you or someone else observes these symptoms. Your doctor may consider a dose reduction.

• Dependence

This medicine can cause dependence.

• Withdrawal symptoms

This medicine can cause opioid withdrawal symptoms if you take it too soon after using opioids. You should wait 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, before taking Suboxone.

This medicine can also cause withdrawal symptoms if you stop taking it suddenly. See section 3 "If you stop taking Suboxone".

• Liver damage

There have been reports of liver damage after taking Suboxone, especially when the medicine is misused. It may also be due to viral infections (e.g. chronic hepatitis C), alcohol abuse, anorexia, or the use of other medicines that can damage the liver (see section 4). Your doctor may perform regular blood tests to monitor your liver function. Tell your doctor if you have any liver problems before starting treatment with Suboxone.

• Blood pressure

This medicine can 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 medicine may mask the symptoms of pain that could help in the diagnosis of some diseases. You should tell your doctor that you are taking this medicine.

Children and adolescents

Do notgive this medicine to children under 15 years. If you are between 15 and 18 years old, your doctor may monitor you more closely during treatment due to the lack of data in this age group.

Other medicines and Suboxone

Tell your doctor if you are taking, have recently taken or might take any other medicines.

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

• Benzodiazepines(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 medicines increases the risk of drowsiness, difficulty breathing (respiratory depression) and coma, and may be potentially life-threatening. For this reason, 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. Tell your doctor about all sedatives you are taking and strictly follow your doctor's dosage recommendation. It may be helpful to inform your friends or family to be alert to the signs and symptoms mentioned above. Contact your doctor if you experience these symptoms.

• Other medicines that can cause drowsinessand are used to treat diseases such as anxiety, insomnia, seizures/epileptic fits or pain. These types of medicines can reduce your level of alertness, making it difficult to drive and use machines. They can also cause central nervous system depression, which is very serious. The following is a list of examples of these types of medicines:

• other medicines that contain opioids such as methadone, some painkillers or cough suppressants;
• antidepressants (used to treat depression) such as isocarboxazid, phenelzine, selegiline, tranylcypromine and valproate may enhance the effects of this medicine;
• sedating H1 receptor antagonists (used to treat allergic reactions) such as diphenhydramine and chlorphenamine;
• barbiturates (used to produce sleep or sedation) such as phenobarbital or secobarbital;
• tranquilizers (used to produce sleep or sedation) such as chloral hydrate.

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

• Clonidine (used to treat high blood pressure) may prolong the effects of this medicine.
• Antiretrovirals (used to treat HIV) such as ritonavir, nelfinavir or indinavir may enhance the effects of this medicine.
• Certain antifungals (used to treat fungal infections) such as ketoconazole, itraconazole or certain antibiotics may prolong the effects of this medicine.
• Some medicines may reduce the effect of Suboxone. These include medicines used to treat epilepsy (carbamazepine and phenytoin) and medicines used to treat tuberculosis (rifampicin).
• Naltrexone and nalmefene (medicines used to treat addictive disorders) may block the therapeutic effects of Suboxone. They should not be taken at the same time as Suboxone treatment as you may experience a sudden onset of prolonged and intense withdrawal.

Using Suboxone with food, drinks and alcohol

Do not drink alcoholwhile you are being treated with this medicine. Alcohol may increase drowsiness and the risk of respiratory failure if taken with Suboxone. Do not swallow or consume food or drinks until the tablet has dissolved completely.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. The risks of using Suboxone in pregnant women are not known. Your doctor will decide whether you should continue your treatment with another medicine.

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

Do not breast-feed while you are taking this medicine, as buprenorphine is excreted in breast milk.

Driving and using machines

Do notdrive or ride a bike, do not use tools or machines, or engage in hazardous activities until you know how this medicine affects you. Suboxone may cause drowsiness, dizziness or impaired thinking. This may occur more frequently in the first few weeks of treatment, when the dose is being changed, but may also occur if you drink alcohol or take other sedative medicines at the same time as taking Suboxone.

Suboxone contains lactose and sodium.

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

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

3. How to take Suboxone

Follow the instructions for administration of this medicine exactly as told by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Treatment is prescribed and supervised by doctors with experience in the treatment of drug addiction.

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

Starting treatment

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

This dose may be repeated on two more occasions on Day 1, depending on your needs.

Before taking your first dose of Suboxone, you must have clear signs of withdrawal. Your doctor will tell you when to take your first dose.

• Starting treatment with Suboxone if you have heroin dependence

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

• Starting treatment with Suboxone if you have methadone dependence

If you have been taking methadone or a long-acting opioid, it is recommended 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 signs of withdrawal appear and at least 24 hours after the last time you used methadone.

How to take Suboxone

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

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

• Do not chew or swallow the tablets, as the medicine will not work and you may experience withdrawal symptoms.

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

How to remove the tablet from the blister pack

If the blister pack is damaged, discard the tablet.

Dose adjustment and maintenance treatment:

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

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

Stopping treatment

Depending on your condition, the dose of Suboxone may be further reduced under close medical supervision until you can eventually stop taking it.

Do not change your treatment in any way or stop it without the authorization 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 or they should go immediately to the emergency department or hospital for treatment, as an overdose of Suboxone can cause serious and potentially life-threatening breathing problems.

Symptoms of overdose may include drowsiness and disorientation with slow reflexes, blurred vision and/or difficulty speaking. You may not be able to think clearly and may breathe much more slowly than usual.

If you forget to take Suboxone

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

If you stop taking Suboxone

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

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Report immediately to your doctor or seek urgent medical attentionif you experience adverse effects such as:

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

Also, report immediately to your doctorif you experience adverse effects such as:

• Intense fatigue, itching with yellowish skin or eye discoloration. These can be signs of liver damage.
• Seeing or hearing things that do not really exist (hallucinations).

Adverse Effects Reported with Suboxone

Misuse of this medicine by injection can cause withdrawal symptoms, infections, other skin reactions, and potentially serious liver problems (see "Warnings and Precautions").

Reporting of Adverse Effects

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

5. Storage of Suboxone

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

Do not use this medicine after the expiration date shown on the box. The expiration date is the last day of the month indicated.

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

Store the blister pack safely.

Never open the blister pack before its time.

Never take this medicine in front of children.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Suboxone

• The active ingredients are buprenorphine and naloxone.

Each 2 mg/0.5 mg sublingual tablet contains 2 mg of buprenorphine (as hydrochloride) and 0.5 mg of naloxone (as dihydrate hydrochloride).

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

Each 16 mg/4 mg sublingual tablet contains 16 mg of buprenorphine (as hydrochloride) and 4 mg of naloxone (as dihydrate hydrochloride).

• The other ingredients 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 Package Contents

Suboxone 2 mg/0.5 mg sublingual tablets are white, hexagonal, and biconvex, 6.5 mm in size, with "N2" engraved on one side.

Suboxone 8 mg/2 mg sublingual tablets are white, hexagonal, and biconvex, 11 mm in size, with "N8" engraved on one side.

Suboxone 16 mg/4 mg sublingual tablets are white, round, and biconvex, 10.5 mm in size, with "N16" engraved on one side.

Packaged in packs of 7 and 28 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Indivior Europe Limited

27 Windsor Place

Dublin 2

D02 DK44

Ireland

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

Date of the Last Revision of this Leaflet:

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