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 alcohol intoxication or if you have 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

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 illnesses 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 remember:

• 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.

• Abuse and misuse

This medicine may be targeted by people who abuse prescription medicines and must 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), possibly fatal, in children and non-dependent persons if ingested accidentally or intentionally.

• Dependence

This medicine can cause dependence.

• Withdrawal symptoms

This medicine can cause opioid withdrawal symptoms if taken 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.

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

• Liver damage

There have been reports of liver damage after taking Suboxone, especially when the medicine is misused. This 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. Inform 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 get 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 inform your doctor that you are taking this medicine.

Children and adolescents

Do not give this medicine to children under 15 years of age. 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 serious. 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 fatal. 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. Inform your doctor about all sedatives you are taking and follow your doctor's dosage recommendation strictly. It may be useful 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 drowsiness and are used to treat diseases such as anxiety, insomnia, seizures/epileptic fits, or pain. This type of medicine 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 this type of medicine:

• 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 can interact with Suboxone, and you may experience symptoms such as involuntary muscle contractions, including muscles that control eye movement, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, and 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 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 decrease 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 breastfeeding

If you are pregnant or breastfeeding, 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, including respiratory problems, in the newborn. This may occur several days after birth.

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

Driving and using machines

Do not drive or ride a bicycle, do not use tools or machines, and do not engage in hazardous activities until you know how this medicine affects you. Suboxone can cause drowsiness, dizziness, or altered thinking. This may occur more frequently in the first few weeks of treatment, when the dose is being changed, but it can also occur if you drink alcohol or take other sedative medicines at the same time as 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 prescribed 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 of age is normally two Suboxone 2 mg/0.5 mg sublingual tablets.

This dose may be repeated on the first day, 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 withdrawal signs 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 withdrawal signs 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, inform 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 gradually reduced under close medical supervision until it can be finally stopped.

Do not change the 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, go or be taken immediately to the emergency department or hospital for treatment, as an overdose of Suboxone can cause serious and potentially fatal respiratory problems.

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

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 who is treating you. Sudden stopping of treatment can 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.
• Drowsiness and disorientation, 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:

• • Severe 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 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).

• 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.

Packaged in packs of 7 and 28 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Indivior Europe Limited

27 Windsor Place

Dublin 2

Ireland

Manufacturer

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 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/.