SUBOXONE 4 mg/1 mg SUBLINGUAL FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Suboxone 2 mg/0.5 mg sublingual film

Suboxone 4 mg/1 mg sublingual film

Suboxone 8 mg/2 mg sublingual film

Suboxone 12 mg/3 mg sublingual film

buprenorphine/naloxone

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Suboxone and what is it used for
2. What you need to know before you take Suboxone
3. How to take Suboxone
4. Possible side effects
5. Storage of Suboxone
6. Contents of the pack and other information

1. What is Suboxone and what is it used for

Suboxone is used to treat opioid dependence (narcotics), such as heroin ormorphine, in patients whohave given their consent to be treated for their addiction.

Suboxone is used in adults and adolescents over 15 yearswho are also receiving medical, social, and psychological support.

2. What you need to know before you take Suboxone

Do not take Suboxone

• if you are allergicto buprenorphine, naloxoneor 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

Consult your doctor before taking Suboxone if you have:

• asthma or other respiratory problems;
• liver problems such as hepatitis;
• low blood pressure;
• a recent head injury or brain disease;
• a urinary disorder (especially associated with an enlarged prostate in men);
• kidney disease;
• thyroid problems;
• adrenal gland disorder (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 consider:

• 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 thismedicine 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 used buprenorphine improperly or took it with other central nervous system depressants, such as alcohol, benzodiazepines (tranquilizers), or other opioids.

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

• 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.

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. 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 performblood tests frequently to monitor the condition of your liver. 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 can 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 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

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

Some medicines can 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 like 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 strictly follow your doctor's dosage recommendation. 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 areused 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 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, 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 can 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 film has dissolved completely.

Pregnancy, breastfeeding, and fertility

Inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. 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 can cause withdrawal symptoms in the newborn, including breathing problems. This can occur several days after birth.

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

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Do notdrive or ride a bike, do notuse tools or machines, do notengage in hazardous activities until you know how this medicine affects you. Suboxone can cause drowsiness, dizziness, or altered thinking. This can occur more frequently in the first 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 taking Suboxone.

Suboxone contains maltitol, orange yellow S (E-110), and sodium.

Suboxone contains liquid maltitol. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Suboxone contains orange yellow S (E-110), which may cause allergic reactions.

This medicine contains less than 1 mmol of sodium (23 mg) per film; i.e., it is essentially "sodium-free".

3. How to Take Suboxone

Follow your doctor's or pharmacist's instructions for taking this medication exactly. If you are unsure, consult your doctor or pharmacist again.

Treatment is prescribed and supervised by doctors with experience in treating 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 two Suboxone 2 mg/0.5 mg sublingual films or one Suboxone 4 mg/1 mg sublingual film.

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

Before taking your first dose of Suboxone, you must be experiencing 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.

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 decrease the dose to a lower maintenance dose.

How to Take Suboxone

• Take the dose once a day, approximately at the same time each day.
• It is recommended to moisten your mouth before taking the film.
• Place the sublingual film under your tongue (sublingually) or inside your cheek (buccally) as directed by your doctor. Make sure the films do not overlap.
• Keep the films under your tongue or inside your cheek until they have completely dissolved.
• Do not chew or swallowthe film, as the medication will not work and you may experience withdrawal symptoms.
• Do not eat or drink until the film has completely dissolved.
• Do not split or cut the film into smaller doses.

How to Remove the Film from the Pouch

Each Suboxone film comes in a child-resistant pouch. Do not open the pouch until you are ready to use it.

To open the pouch, locate the perforated line on the top edge of the pouch and fold the edge of the pouch along this line (see Figure 1).

Figure 1

• When you fold the pouch along the perforated line, a slit appears in the folded edge of the pouch that can be torn along the arrow.

• Alternatively, you can cut the pouch with scissors along the arrow (see Figure 2).

Figure 2

If the pouch is damaged, discard the film.

How to Place a Film Under Your Tongue (Sublingually):

First, drink water to moisten your mouth. This helps the film dissolve more easily. Then, hold the film between two fingers by the outer edges, and place it under your tongue, near the base, either on the right or left side (see Figure 3).

Figure 3

If your doctor has instructed you to take two films at the same time, place the second film under your tongue on the other side. Make sure the films do not overlap.

If your doctor has instructed you to take a third film, place it under your tongue on either side after the first two have dissolved.

How to Place a Film Inside Your Cheek (Buccally):

Drink water to moisten your mouth. Hold the film between two fingers by the outer edges, and place it inside your cheek, either on the right or left side (see Figure 4).

Figure 4

If your doctor has instructed you to take two films at the same time, place the second film inside the other cheek; this will ensure the films do not overlap. If your doctor has instructed you to take a third film, place it inside your cheek on either side after the first two have dissolved.

If You Take More Suboxone Than You Should

If you or someone else takes too much of this medication, seek urgent medical attention.

Overdose of Suboxone can cause serious and potentially life-threatening breathing problems.

Overdose symptoms 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 for you.

If You Miss a Dose of Suboxone

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

If You Stop Treatment with Suboxone

Sudden interruption of treatment can cause withdrawal symptoms.Depending on your condition, the dose of Suboxone may continue to be decreased under close medical supervision until it can finally be stopped. Do not change your treatment in any way or stop it without the authorization of the doctor treating you.

If you have any other questions about using this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

Tell your doctor or seek urgent medical attention immediatelyif you experience side effects such as:

• Swelling of the face, lips, tongue, or throat, which can cause difficulty swallowing or breathing; severe hives/urticaria. 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 more slowly than usual for you.
• Extreme tiredness, itching with yellowing of the skin or eyes. These can be signs of liver damage.
• Seeing or hearing things that do not really exist (hallucinations).

Very Common Side Effects (may affect more than 1 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 hands and feet,
• drowsiness,
• anxiety,
• nervousness,
• tingling,
• depression,
• decreased sexual desire,
• increased muscle tension,
• abnormal thinking,
• increased tear production (watery eyes) or other tear disorders,
• hot flashes,
• increased blood pressure,
• migraines,
• runny nose,
• throat pain and difficulty swallowing,
• increased cough,
• stomach upset or other stomach discomfort,
• diarrhea,
• mouth redness,
• abnormal liver function,
• flatulence,
• vomiting,
• skin rash,
• itching,
• hives,
• pain,
• joint pain,
• muscle pain,
• leg cramps (muscle spasms),
• difficulty getting or maintaining an erection,
• urine abnormalities,
• abdominal pain,
• back pain,
• weakness,
• infection,
• chills,
• chest pain,
• fever,
• flu-like symptoms,
• general feeling of discomfort,
• accidental injury due to loss of alertness or coordination,
• fainting,
• dizziness.

Uncommon Side Effects (may affect up to 1 in 100 people):

• inflamed glands (lymph nodes),
• agitation,
• tremors,
• abnormal dreams,
• excessive muscle activity,
• depersonalization (feeling not like oneself),
• drug dependence,
• amnesia (memory disorder),
• loss of interest,
• attention disorder,
• exaggerated feeling of well-being,
• seizure (epileptic fits),
• speech disorder,
• small pupils,
• difficulty urinating,
• blurred vision,
• eye inflammation or infection,
• rapid or slow heartbeat,
• low blood pressure,
• palpitations,
• heart attack,
• chest tightness,
• shortness of breath,
• asthma,
• yawning,
• mouth problems (sores, blisters, numbness, tingling, swelling, or pain),
• tongue discoloration or pain,
• acne,
• skin nodule,
• hair loss,
• dry or flaky skin,
• joint inflammation,
• urinary tract infection,
• abnormal blood tests,
• blood in the urine,
• abnormal ejaculation,
• menstrual or vaginal problems,
• kidney stone,
• protein in the urine,
• pain or difficulty urinating,
• sensitivity to heat or cold,
• heat stroke,
• allergic reaction,
• loss of appetite,
• hostile feelings,
• poisoning.

Frequency Not Known (cannot be estimated from the available data):

• sudden withdrawal syndrome caused by taking Suboxone too soon after taking illegal opioids,
• drug withdrawal syndrome in newborns,
• slow or difficult breathing,
• liver damage with or without jaundice,
• hallucinations,
• swelling of the face and throat or potentially life-threatening allergic reactions,
• drop in blood pressure when changing from a sitting or lying position to standing, causing dizziness,
• irritation or inflammation of the mouth, including under the tongue.

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

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Suboxone

Keep this medication out of sight and reach of children and other family members. Do not use this medication after the expiration date shown on the carton and pouch. The expiration date is the last day of the month indicated.

Store below 25°C.

Suboxone may be a target for people who abuse prescription medications.

Keep this medication in a safe place to protect it from theft.

Store the pouch safely.

Never open the pouch before it is time.

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

6. Package Contents and Additional Information

Suboxone Composition

• The active ingredients are buprenorphine and naloxone.

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

Each 4 mg/1 mg film contains 4 mg of buprenorphine (as hydrochloride) and 1 mg of naloxone (as hydrochloride dihydrate).

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

Each 12 mg/3 mg film contains 12 mg of buprenorphine (as hydrochloride) and 3 mg of naloxone (as hydrochloride dihydrate).

• The other ingredients are macrogol, liquid maltitol, natural lime flavor, hypromellose, citric acid, potassium acesulfame, sodium citrate, orange yellow S (E-110), and white ink.

Product Appearance and Packaging Contents

Suboxone 2 mg/0.5 mg sublingual films are orange rectangular films with nominal dimensions of 22.0 mm × 12.8 mm, with “N2” engraved in white ink.

Suboxone 4 mg/1 mg sublingual films are orange rectangular films with nominal dimensions of 22.0 mm × 25.6 mm, with “N4” engraved in white ink.

Suboxone 8 mg/2 mg sublingual films are orange rectangular films with nominal dimensions of 22.0 mm × 12.8 mm, with “N8” engraved in white ink.

Suboxone 12 mg/3 mg sublingual films are orange rectangular films with nominal dimensions of 22.0 mm × 19.2 mm, with “N12” engraved in white ink.

The films are packaged in individual pouches.

Package sizes: boxes containing 7 × 1, 14 × 1, and 28 × 1 films.

Only some package sizes may be marketed.

Marketing Authorization Holder

Indivior Europe Limited

27 Windsor Place

Dublin 2

Ireland

Manufacturer

Almac Pharma Services Limited

Seagoe Industrial Estate, Portadown

Craigavon BT63 5UA

United Kingdom

Almac Pharma Services (Ireland) Limited

Finnabair Industrial Estate, Dundalk

Co. Louth A91 P9KD

Ireland

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

Date of Last Revision of this Leaflet:{month YYYY}.

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