Buprenorphine Sun

Package leaflet: Information for the user

Buprenorfine SUN 2 mg sublingual tablets, 8 mg sublingual tablets

buprenorphine hydrochloride
Equivalent medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Buprenorfine SUN is and what it is used for

Buprenorphine belongs to a group of medicines called opioid analgesics (also known as 'opiates' or 'narcotics'). Opioid analgesics, such as morphine or diamorphine (heroin), are often subject to abuse, which can lead to dependence. If you are dependent on these medicines, you need a regular dose to feel 'normal'; otherwise, you will develop withdrawal symptoms within about one day of taking the last dose. Withdrawal symptoms include sweating, hot and cold sensations, tearing, runny nose, feeling unwell or malaise, diarrhoea, stomach cramps, insomnia, and severe discomfort.

Buprenorfine SUN is used in the substitution treatment of patients dependent on opioid drugs, such as heroin and morphine. The tablets prevent or reduce the unpleasant withdrawal symptoms experienced by patients dependent on opioid drugs when stopping treatment.

Treatment with Buprenorfine SUN may form part of a specialist support programme aimed at overcoming opioid dependence.

Treatment with Buprenorfine SUN is used in adults and adolescents aged 16 years and older who have given consent to undergo treatment for opioid dependence.

2. What you should know before taking Buprenorfina SUN

Do not take Buprenorfina SUN

• if you are allergic to buprenorphine or to any of the other ingredients of this medicine (listed in section 6)
• if you are a child under 15 years of age
• if you have severe respiratory problems
• if you have severe liver disease
• if you are an alcoholic or regularly drink large amounts of alcohol (more than two drinks per day for men and more than one drink per day for women (e.g., one drink = one 350 ml bottle of beer (4.5% alcohol) or one 150 ml glass of wine (12.9% alcohol))
• if you suffer from delirium tremens (confusion and seizures after stopping alcohol consumption; hallucinations (seeing and hearing things that are not real))
• if you are breastfeeding.

Warnings and precautions

• Consult your doctor or pharmacist before taking Buprenorfina SUN if any of the following conditions apply to you before starting treatment or develop during treatment, as your doctor may need to reduce the dose of Buprenorfina SUN or you may require additional treatment to manage them:
  • epileptic seizures
  • asthma or other breathing problems
  • kidney problems
  • liver problems
  • head injury or brain disease
  • low blood pressure
  • in men: urinary problems (especially related to an enlarged prostate)
  • thyroid problems
  • adrenocortical disorders (e.g., Addison's disease)
  • depression or other conditions treated with antidepressants.

The use of these medicines together with Buprenorfina SUN may lead to serotonin syndrome,
a condition that can be fatal (see "Other medicines and Buprenorfina SUN").
It is important to know that
Misuse, abuse, and diversion
This medicine may be targeted by individuals who abuse prescription medicines and must be stored securely to prevent theft. Do not give this medicine to anyone else. It may cause death or harm to others.
Breathing problems
Some people have died from respiratory failure (inability to breathe) following misuse of buprenorphine or its concomitant use with other central nervous system depressants such as alcohol, benzodiazepines (medicines used to treat anxiety or sleep disorders), or other opioids.
Dependence
This medicine may cause dependence.
Withdrawal symptoms
This medicine may cause withdrawal symptoms if taken less than 4–6 hours after using narcotics such as morphine or heroin, or less than 24 hours after using methadone.
Buprenorfina SUN may cause withdrawal symptoms if treatment is stopped abruptly.
Liver damage
Cases of severe liver damage have been reported following misuse of the medicine, particularly when administered intravenously and at high doses. These effects may be worsened by viral infections (e.g., chronic hepatitis C), alcohol abuse, anorexia, and other medicines that may damage the liver (e.g., antiretroviral medicines, acetylsalicylic acid (aspirin), amiodarone, isoniazid, valproate). Inform your doctor immediately if you experience symptoms such as severe fatigue, loss of appetite, itching, or yellowing of the skin or eyes; your doctor will prescribe appropriate treatment. Your doctor may request regular blood tests to monitor your liver function. Inform your doctor if you have any liver problems before starting treatment with Buprenorfina SUN.
Blood pressure
This medicine may cause a sudden drop in blood pressure, leading to dizziness when rising too quickly from a sitting or lying position.
Diagnosis of unrelated medical conditions
This medicine may mask pain symptoms that could assist in diagnosing certain diseases. Remember to inform your doctor if you are taking this medicine.
Drowsiness
Drowsiness, which may be worsened by alcohol or tranquilizers or medicines for anxiety. If drowsiness occurs, do not drive or operate machinery.
For athletes: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.
Sleep-related breathing disorders
Buprenorfina SUN 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 breathing pauses during sleep, nighttime awakenings due to shortness of breath, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else notices these symptoms, contact your doctor. Your doctor may consider reducing the dose.
Children and adolescents
There are no data available on the treatment of adolescents (16–18 years); patients in this age group should be monitored more closely during treatment.
Other medicines and Buprenorfina SUN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular, inform your doctor if you are taking or have recently taken any of the following medicines, as they may interact with Buprenorfina SUN.
The following medicines have sedative effects (cause drowsiness). These effects increase when taken concomitantly with Buprenorfina SUN:

• benzodiazepines (used to treat anxiety or sleep disorders), e.g., diazepam, temazepam, alprazolam: do not take these medicines together with Buprenorfina SUN unless prescribed by your doctor. The combination of these medicines can be fatal if the dose is not carefully determined
• other medicines containing opioids, strong painkillers, or cough suppressants containing opioid-related medicines, e.g., codeine, dihydrocodeine, methadone, and morphine
• medicines for depression, including those known as monoamine oxidase inhibitors (MAOIs), e.g., phenelzine
• antidepressants such as moclobemide, tranylcypromine, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, duloxetine, venlafaxine, amitriptyline, doxepin, or trimipramine. These medicines may interact with Buprenorfina SUN and may cause symptoms such as involuntary rhythmic muscle contractions, including muscles controlling eye movement, agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle contraction, and fever above 38°C. Contact your doctor if you experience such symptoms.
• antihistamines (used to treat allergies and/or hay fever), e.g., promethazine and chlorpheniramine
• barbiturates and other medicines for anxiety or sleep disorders
• medicines known as antipsychotics (used to treat schizophrenia), e.g., chlorpromazine and haloperidol
• certain medicines for high blood pressure (antihypertensives), e.g., clonidine.

Concomitant use of Buprenorfina SUN with sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. For this reason, concomitant use should only be considered when no other treatment options are possible.
However, if your doctor prescribes Buprenorfina SUN together with sedative medicines, the dose and duration of concomitant treatment must be limited by your doctor.
Inform your doctor about all sedative medicines you are taking and follow your doctor’s dosage recommendations carefully.
It may be helpful to inform friends or family members to watch for the symptoms listed above. Contact your doctor if such symptoms occur.
If you are taking any of the following medicines, your doctor may need to prescribe a lower dose of Buprenorfina SUN:

• the antifungal ketoconazole (which may increase Buprenorfina SUN blood levels when taken concomitantly)
• medicines used to treat viral infections (antiviral agents), e.g., ritonavir, saquinavir, and indinavir, used to treat HIV infections
• oral contraceptives containing gestodene
• certain antibiotics called 'macrolide antibiotics' (used to treat infections), e.g., troleandomycin.

If you are taking any of the following medicines, your doctor may need to prescribe a higher dose of Buprenorfina SUN:

• anticoagulants, phenprocoumon (to thin the blood).

If you are taking any of the following medicines, your doctor may need to prescribe a higher dose of Buprenorfina SUN or a lower dose of the following medicines:

• medicines for epilepsy, e.g., phenobarbital, carbamazepine, and phenytoin
• the antibiotic rifampicin (for the treatment of tuberculosis).

Concomitant use of Buprenorfina SUN and the following medicines may cause withdrawal symptoms:

• methadone (for opioid addiction treatment)
• naltrexone (used to maintain abstinence from heroin, methadone, and other opioids that cause addiction).

Buprenorfina SUN with food, drinks, and alcohol
Do not consume alcohol or medicines containing alcohol during treatment with Buprenorfina SUN. Alcohol increases the sedative effects of buprenorphine, making driving and operating machinery dangerous.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Buprenorfina SUN should only be used during pregnancy if the potential benefits outweigh the risks. Inform your doctor if you are pregnant or trying to become pregnant. If you become pregnant during treatment with buprenorphine, inform your doctor immediately. Your doctor will decide whether to continue treatment with an alternative medicine.
Buprenorfina SUN passes into breast milk: do not breastfeed during treatment with this medicine.
Driving and using machines
Buprenorfina SUN may cause drowsiness, especially when taken with alcohol or certain antidepressants. If you experience drowsiness during treatment with this medicine, do not drive or operate machinery.
Buprenorfina SUN contains lactose, butylated hydroxyanisole, and sodium
Buprenorfina SUN sublingual tablets contain lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
Buprenorfina SUN sublingual tablets contain butylated hydroxyanisole (E320), which may cause local skin reactions (e.g., contact dermatitis) or irritation to the eyes and mucous membranes.
This medicine contains less than 1 mmol (23 mg) of sodium per maximum daily dose, i.e., essentially 'sodium-free'.
3. How to take Buprenorfina SUN
Always take this medicine exactly as your doctor has instructed. If you have any doubts, consult your doctor or pharmacist.
Your doctor may perform some liver function tests before starting treatment with Buprenorfina SUN and then regularly during treatment.
To avoid sudden withdrawal symptoms, treatment with Buprenorfina SUN should be initiated only when clear signs of withdrawal are present.
Dosage
Adults and adolescents aged 15 years and older
The usual dose ranges from 0.8 mg to 4 mg, taken once daily. The 0.4 mg Buprenorfina SUN dosage is not available. If a lower dose is required, use 0.4 mg tablets from another pharmaceutical company.
Patients with untreated opioid dependence
Buprenorfina SUN should be taken at least 4–6 hours after the last dose of an opioid (narcotic, such as morphine or heroin) or when the first signs of withdrawal appear. Taking the medicine before 4–6 hours have passed since narcotic use may cause sudden withdrawal symptoms.
Patients taking methadone
Your doctor may reduce your methadone dose to no more than 30 mg per day before starting treatment with Buprenorfina SUN. Buprenorfina SUN may cause withdrawal symptoms in methadone-dependent patients if taken within 24 hours of the last methadone dose.
Use in children and adolescents (< 15 years)
There are no clinical data on the efficacy and safety of Buprenorfina SUN in children and adolescents. Therefore, do not administer Buprenorfina SUN to children and adolescents under 15 years of age.
How to take Buprenorfina SUN
Do not take the tablets with food or drinks.
The tablets are 'for sublingual use'. This means that the tablet must be placed under the tongue until it dissolves completely, which usually takes 5–10 minutes. Do not chew or swallow the tablets whole – the medicine would not be effective and withdrawal symptoms may occur.
How long to take Buprenorfina SUN
During treatment, your doctor may increase the dose of Buprenorfina SUN up to 24 mg/day, depending on your condition. Once stability is achieved, your doctor will gradually reduce the dose.
Under close medical supervision, the dose will be progressively reduced until treatment is completely discontinued.
The effectiveness of this treatment depends on the dose and on concomitant medical, psychological, and social therapy.
If you feel that the effect of Buprenorfina SUN is too strong or too weak, inform your doctor or pharmacist.
If you take more Buprenorfina SUN than you should
Inform your doctor immediately or go to the nearest hospital emergency department. Remember to bring the package and any remaining tablets with you, as an overdose of Buprenorfina SUN may cause serious and potentially fatal breathing problems.
If you forget to take Buprenorfina SUN
Inform your doctor and follow their instructions. Do not take a double dose to make up for a missed dose unless instructed by your doctor.
If you stop taking Buprenorfina SUN
Do not stop taking the tablets abruptly unless instructed by your doctor, as this may cause withdrawal symptoms.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
All medicines can cause allergic reactions, although serious ones are very rare. Contact your doctor immediately or seek urgent medical attention if you experience any of the following side effects:

• suddenly becoming breathless, difficulty breathing, swelling of the eyelids, face, tongue, lips, throat or hands, rash or itching all over the body. These could be signs of a potentially life-threatening allergic reaction
• feeling faint, as this may be a sign of low blood pressure.

Also contact your doctor immediately if you experience any of the following side effects:

• fatigue (tiredness), loss of appetite, or if your skin or eyes turn yellow. These could be symptoms of liver damage.

The following side effects have also been reported:
Very common (may affect more than 1 in 10 people)

• withdrawal syndrome, headache, hyperhidrosis (excessive sweating), insomnia (inability to sleep), nausea (feeling unwell), pain.

Common (may affect up to 1 in 10 people)

• abdominal pain, agitation, anxiety, joint pain, weakness, back pain, bone pain, bronchitis, chest pain, chills, constipation, cough, decreased appetite, depression, diarrhoea, miosis (pupil constriction), dizziness, dry mouth, painful menstrual cycle, indigestion, shortness of breath, flatulence, gastrointestinal disorders, hostility, increased muscle tension, infection, influenza, nervousness, lacrimation disorders (watery eyes), swollen glands (lymph nodes), malaise, migraine, muscle spasms, muscle pain, pupil dilation, neck pain, palpitations, paranoia, burning or tingling sensations in hands and feet, sweating (hands and feet), runny or stuffy nose, sore throat and painful swallowing, fever, rash, somnolence, syncope (fainting), abnormal thinking, dental disorders, tremor, flushing, vomiting (feeling unwell), yawning.

Rare (may affect up to 1 in 1,000 people)

• allergy (hypersensitivity)
• euphoria
• hallucinations
• breathing problems

Frequency not known (cannot be estimated from the available data)

• drug dependence, neonatal opioid withdrawal syndrome, hallucinations (seeing things that are not real), drop in blood pressure when moving from sitting or lying down to standing up, severe difficulty in urinating
• misuse of this medicine when administered by injection may cause withdrawal symptoms, infections, other skin reactions and potentially serious liver problems (see ‘Take special care with Buprenorphine SUN’).

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Buprenorphine SUN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Buprenorphine SUN contains

• The active substance is buprenorphine. Buprenorphine SUN 2 mg: each tablet contains 2.16 mg of buprenorphine hydrochloride, equivalent to 2 mg of buprenorphine. Buprenorphine SUN 8 mg: each tablet contains 8.62 mg of buprenorphine hydrochloride, equivalent to 8 mg of buprenorphine.
• The other ingredients are monohydrate lactose, mannitol, anhydrous citric acid, dihydrate sodium citrate, povidone K30, butylated hydroxyanisole (E320), maize starch, pregelatinized maize starch, magnesium stearate.

Description of the appearance of Buprenorphine SUN and package contents
Buprenorphine SUN 2 mg sublingual tablet: white to off-white, round, biconvex, uncoated tablet with "2" engraved on one side and smooth on the other.
Buprenorphine SUN 8 mg sublingual tablet: white to off-white, round, biconvex, uncoated tablet with "8" engraved on one side and smooth on the other.
The tablets are marketed in blisters of 7 and 28 sublingual tablets.
It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands

Manufacturer
Alkaloida Chemical Company
Kabay János út 29
4440 Tiszavasvári
Hungary

Legal representative in Italy:
Sun Pharma Italia Srl
Viale Giulio Richard, 3
20143 Milano

This medicinal product is authorised in the European Economic Area (EEA) Member States and the United Kingdom (Northern Ireland) under the following names:
Italy: Buprenorphine SUN 2 mg sublingual tablets
Buprenorphine SUN 8 mg sublingual tablets
The Netherlands: Buprenorphine SUN 2 mg tabletten voor sublinguaal gebruik
Buprenorphine SUN 8 mg tabletten voor sublinguaal gebruik
United Kingdom (Northern Ireland): Buprenorphine 2 mg sublingual tablets
Buprenorphine 8 mg sublingual tablets