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«1 Package leaflet: Information for the user Suboxone 8 mg/2 mg sublingual tablets buprenorphine / naloxone Read all of this leaflet carefully before ...»

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B. PACKAGE LEAFLET

1

Package leaflet: Information for the user

Suboxone 8 mg/2 mg sublingual tablets

buprenorphine / naloxone

Read all of this leaflet carefully before you start taking this 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

 If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

What is in this leaflet

1. What Suboxone is and what it is used for

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

3. How to take Suboxone

4. Possible side effects 5 How to store Suboxone

6. Content of the pack and other information

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.

2. What do you need to know before you take Suboxone Do not take Suboxone  if you are allergic (hypersensitive) to buprenorphine, naloxone or any of the other ingredients of this medicine (see section 6)  if you have serious breathing problems  if you have serious liver problems  if you are intoxicated due to alcohol or have trembling, 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

Talk to your doctor before taking Suboxone if you have:

 asthma or other breathing problems  any liver disease such as hepatitis  low blood pressure  recently suffered a head injury or brain disease  a urinary disorder (especially linked to enlarge prostrate in men)  any kidney disease.

2  thyroid problems  adrenocortical disorder (e.g. Addison’s disease)

Important things to be aware of:

 Additional monitoring You may be more closely monitored by your doctor if you are below the age of 18 or over the age of 65. This medicine should not be taken by those under 15 years of age.

 Misuse and abuse This medicine can be a target for people who abuse prescription medicines, and should be kept in a safe place to protect it from theft. Do not give this medicine to anyone else. It can cause death or otherwise harm them.

 Breathing problems Some peoplehave died from respiratory failure (inability to breathe) because they misused this medicine or took it in combination with other central nervous system depressants, such as alcohol, benzodiazepines (tranquilisers), or other opioids.

This medicine may cause severe, possibly fatal, respiratory depression (reduced ability to breathe) in children and non-dependent people who accidentally or deliberately take it.

 Dependence This product can cause dependence.

 Withdrawal symptoms This product can cause withdrawal symptoms if you take it less than six hours after you use a short-acting opioid (e.g. morphine, heroin) or less than 24 hours after you use a long-acting opioid such as methadone.

Suboxone can also cause withdrawal symptoms if you stop taking it abruptly.

 Liver damage Liver damage has been reported after taking Suboxone, especially when the medicine is misused.

This could also be due to viral infections (chronic hepatitis C), alcohol abuse, anorexia or use of other medicines with the ability to harm your liver (see section 4). Regular blood tests may be conducted by your doctor to monitor the condition of your liver. Tell your doctor if you have any liver problems before you start treatment with Suboxone.

 Blood pressure This product may cause your blood pressure to drop suddenly, causing you to feel dizzy if you get up too quickly from sitting or lying down.

 Diagnosis of unrelated medical conditions This medicine may mask pain symptoms that could assist in the diagnosis of some diseases. Do not forget to advise your doctor if you take this medicine.

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 and may sometimes cause very serious reactions. Do not take any other medicines whilst taking Suboxone without first talking to your doctor

especially:

–  –  –

 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 will 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 pain killers and cough suppressants





- anti-depressants (used to treat depression) such as isocarboxazide, phenelzine, selegiline, tranylcypromine and valproate may increase the effects of this medicine.

- sedative Hı 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.

 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 ketoconzaole, 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 (drugs 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 Alcohol may increase drowsiness and may increase the risk of respiratory failure if taken with Suboxone. Do not take Suboxone together with alcohol. Do not swallow or consume food or any drink until the tablet is completely dissolved.

Pregnancy and breast-feeding The risks of using Suboxone in pregnant women are not known. Tell your doctor if you are pregnant or intend to become pregnant. Your doctor will decide if your treatment should be continued with an alternative medicine.

When taken during pregnancy, particularly late pregnancy, medicines like Suboxone may cause drug withdrawal symptoms including problems with breathing in your newborn baby. This may appear several days after birth.

Do not breast-feed whilst taking this medicine, since Suboxone passes into breast milk.

Ask your doctor or pharmacist for advice before taking any medicine.

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

–  –  –

3. How to take Suboxone 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.

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

Starting treatment The recommended starting dose for adults and adolescents over the age of 15 years is one to two tablets of Suboxone 2 mg/0.5 mg. An additional one to two tablets of the Suboxone 2 mg/0.5 mg may be administered on day 1 depending on your needs.

Clear signs of withdrawal should be evident before taking your first dose of Suboxone. A doctor’s assessment of your readiness for treatment will guide the timing of your first Suboxone dose.

 Starting treatment of Suboxone whilst dependent on heroin If you are dependent upon heroin or a short acting opioid, your first dose of Suboxone should be taken when signs of withdrawal appear, but not less than 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, but not less than 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 5minutes.

 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.

–  –  –

If the blister is damaged, discard the tablet

Dosage 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 have the impression that the effect of Suboxone is too strong or too weak, talk to your doctor or pharmacist. The maximum daily dose is 24.

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

Stopping treatment Depending on your condition, the dose of Suboxone may continue to be reduced under careful medical supervision, until eventually it may be stopped.

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.

–  –  –

Like all medicines, Suboxone 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 effect more than one in 10 people):

Insomnia (inability to sleep), constipation, nausea, excessive sweating, headache, drug withdrawal syndrome

Common side effects (may effect up to 1 in 10 people):

Weight loss, swelling (hands and feet), drowsiness, anxiety, nervousness, tingling, depression, decreased sexual drive, increase in muscle tension, abnormal thinking, increased tearing (watering eyes) or other tearing disorder, 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 effect up to 1 in 100 people):

Swollen glands (lymph nodes), agitation, tremor, abnormal dream, excessive muscle activity, depersonalisation (not feeling like yourself), medicine dependence, amnesia (memory disturbance), loss of interest, exaggerated feeling of well being, convulsion (fits), speech disorder, small pupil size, difficulty urinating, eye inflammation or infection, rapid or slow heart beat, low blood pressure, palpitations, myocardial infarction (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):



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