SUBOXONE 16 MG / 4 MG SUBLINGUAL TABLETS - patient leaflet, side effects, dosage

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.

• 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.

What is in this leaflet

• 1. What Suboxone is and what it is used for

• 2. What you need to know before you take Suboxone

• 3. How to take Suboxone

• 4. Possible side effects

• 5 How to store Suboxone

• 6. Contents of the pack and other information

This medicine contains buprenorphine which is an opioid, which can cause addiction. You can get withdrawal symptoms if you stop taking it suddenly.

1. what suboxone is and what it is used for

Suboxone is used to treat dependence on opioid (narcotic) drugs such as heroin or morphine in drug addicts who have agreed to be treated for their addiction. Suboxone is used in adults and adolescents over 15 years of age, who are also receiving medical, social and psychological support.

This medicine contains buprenorphine which belongs to a class of medicines called opioids.

This medicine has been prescribed to you and should not be given to anyone else. Opioids can cause addiction and you may get withdrawal symptoms if you stop taking it suddenly. Your prescriber should have explained how long you will be taking it for and when it is appropriate to stop, how to do this safely.

2. what you need to know before you take suboxone if you are allergic to buprenorphine, naloxone or any of the other ingredients of this medicine

(listed in section 6)

Warnings and precautions

• seizures, fits or convulsions
• asthma or other breathing problems
• problems with your liver such as hepatitis
• low blood pressure
• recently suffered a head injury or brain disease
• a urinary disorder (especially linked to enlarged prostrate in men)
• any kidney disease
• thyroid problems
• adrenocortical disorder (e.g. Addison’s disease)
• depression or other conditions that are treated with antidepressants. The use of these medicines

together with Suboxone can lead to serotonin syndrome, a potentially life-threatening condition (see ‘’Other medicines and Suboxone’’).

Important things to be aware of:

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

Children and adolescents

Do not give this medicine to children under the age of 15. If you are between 15 and 18 years old your doctor may monitor you more closely during treatment, because of 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 side effects of Suboxone, these can be serious. Do not take any other medicines whilst taking Suboxone without first talking to your doctor, especially:

• Benzodiazepines (used to treat anxiety or sleep disorders) such as diazepam, temazepam,

alprazolam. Concomitant use of Suboxone and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible. However if your doctor does prescribe Suboxone together with sedative medicines the dose and duration of concomitant treatment should be limited by your doctor. Please tell your doctor about all sedative medicines you are taking, and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.

• Other medicines that may make you feel sleepy which are used to treat illnesses such as

anxiety, sleeplessness, convulsions/se­izures, pain. These types of medicines may reduce your alertness levels making it difficult for you to drive and use machines. They may also cause central nervous system depression, which is very serious. Below is a list of examples of these types of medicines:

• – Other opioid containing medicines such as methadone, certain painkillers and cough

suppressants

• – Antidepressants (used to treat depression) such as isocarboxazid, phenelzine, selegiline,

tranylcypromine and valproate may increase the effects of this medicine.

• – Sedative Hi receptor antagonists (used to treat allergic reactions) such as diphenhydramine and

chlorphenamine.

• – Barbiturates (used to cause sleep or sedation) such as phenobarbital, secobarbital

• – Tranquilisers (used to cause sleep or sedation) such as chloral hydrate.

• Anti-depressants such as moclobemide, tranylcypromine, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, duloxetine, venlafaxine, amitriptyline, doxepine, or trimipramine. These medicines may interact with Suboxone and you may experience symptoms such as involuntary, rhythmic contractions of muscles, including the muscles, that control movement of the eye, agitation, hallucinations, coma, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor when experiencing such symptoms.
• Clonidine (used to treat high blood pressure) may extend the effects of this medicine.
• Anti-retrovirals (used to treat HIV) such as ritonavir, nelfinavir, indinavir may increase the effects of this medicine.
• Some antifungal agents (used to treat fungal infections) such as ketoconazole, itraconazole,

certain antibiotics, may extend the effects of this medicine.

• Some medicines may decrease the effect of Suboxone. These include medicines used to treat

epilepsy (such as carbamazepine and phenytoin), and medicines used to treat tuberculosis (rifampicin).

• Naltrexone and nalmefene (medicines used to treat addictive disorders) may prevent the therapeutic effects of Suboxone. They should not be taken at the same time as Suboxone treatment because you may experience a sudden onset of prolonged and intense withdrawal.

Suboxone with food, drink and alcohol

Do not have alcohol whilst being treated with this medicine. Alcohol may increase drowsiness and may increase the risk of respiratory failure if taken with Suboxone. Do not swallow or consume food or any drink until the tablet is completely dissolved.

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.

Do not take Suboxone if you are pregnant or think you might be pregnant unless you have discussed this with your prescriber and the benefits of treatment are considered to outweigh the potential harm to the baby. Your doctor will decide if your treatment should be continued with an alternative medicine.

If you use Suboxone during pregnancy, your baby may become dependent and experience withdrawal symptoms including problems with breathing after the birth which may need to be treated. This may appear several days after birth.

Do not take Suboxone while you are breastfeeding as buprenorphine passes into breast milk and will affect your baby.

Driving and using machines

Do not drive, cycle, use any tools or machines, or perform dangerous activities until you know how this medicine affects you. Suboxone may cause drowsiness, dizziness or impair your thinking. This may happen more often in the first few weeks of treatment when your dose is being changed, but it can also happen if you drink alcohol or take other sedative medicines at the same time as when you take Suboxone.

The medicine can affect your ability to drive as it may make you sleepy or dizzy.

• Do not drive while taking this medicine until you know how it affects you.
• It is an offence to drive if this medicine affects your ability to drive.
• However, you would not be committing an offence if:

o The medicine has been prescribed to treat a medical or dental problem and

o You have taken it according to the instructions given by the prescriber or in the information

provided with the medicine and

o It was not affecting your ability to drive safely

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

◦

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

This medicine contains less than 1 mmol sodium (23 mg) tablet, that is to say essentially ‘sodium-free’.

3. how to take suboxone

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Your treatment is prescribed and monitored by doctors who are experienced in the treatment of drug dependence.

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

Your prescriber should discuss your treatment and whether you need to continue taking tablets at regular intervals. If you and your prescriber decide to stop treatment, a plan will be put in place to gradually reduce the dose and stop taking the medicine to minimise the risk of withdrawal effects.

Starting treatment

The recommended starting dose for adults and adolescents over the age of 15 years is usually two Suboxone 2 mg/0.5 mg sublingual tablets.

This dose may be repeated to twice on day 1 depending on your needs.

You should be aware of the clear signs of withdrawal before taking your first dose of Suboxone. Your doctor will tell you when to take your first dose.

• Starting treatment of Suboxone whilst dependent on heroin

If you are dependent upon heroin or a short acting opioid, your first dose should be taken when signs of withdrawal appear, at least 6 hours after you last used opioids.

• Starting treatment of Suboxone whilst dependent on methadone

If you have been taking methadone or a long acting opioid, the dose of methadone should ideally be reduced to below 30 mg/day before beginning Suboxone therapy. The first dose of Suboxone should be taken when signs of withdrawal appear, and at least 24 hours after you last used methadone.

Taking Suboxone

• Take the dose once a day by placing the tablets under the tongue.
• Keep the tablets in place under the tongue until they have completely dissolved. This may take

5–10 minutes.

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

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

How to remove the tablet from the blister

1 – Do not push the tablet through the foil.

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

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

Do not suddenly stop taking this medicine. If you want to stop taking this medicine, discuss this with your prescriber first. They will tell you how to do this, usually by reducing the dose gradually so that any unpleasant withdrawal effects are kept to a minimum. Withdrawal symptoms such as restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating may occur if you suddenly stop taking this medicine.

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 lifethreatening 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.

4. 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 and addiction, amnesia (memory disturbance), loss of interest, exaggerated feeling of wellbeing, seizures, 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).

Drug Withdrawal

When you stop taking Suboxone, you may experience drug withdrawal symptoms, which include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating.

Reporting of side effects

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 Yellow Card Scheme website: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. 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.

6. Content of the pack and other information

– The active substances are buprenorphine and naloxone.

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

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

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

• – The other ingredients are lactose monohydrate, mannitol, maize starch, povidone K30, citric

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

Indivior UK Limited

The Chapleo Building

Henry Boot Way

Priory Park

Hull

HU4 7DY

United Kingdom

Manufacturer

Reckitt Benckiser Healthcare (UK) Ltd,

Dansom Lane,

Hull,

East Yorkshire HU8 7DS,

United Kingdom.

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

Indivior UK Limited

Tel: 0808 234 9243

e-mail:

This leaflet was last revised in {month YYYY}.

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